Adrenaline (Epinephrine) Injection BP 1 in 1000 (hameln pharmaceuticals ltd)

1. Name Of The Medicinal Product

Adrenaline (Epinephrine) Injection BP 1 in 1000.

2. Qualitative And Quantitative Composition

Each ml of solution for injection contains 1 mg of adrenaline (epinephrine) as the acid tartrate.

3. Pharmaceutical Form

Sterile Injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Adrenaline Injection BP 1 in 1000 may be used in the treatment of acute allergy and anaphylactic shock.

4.2 Posology And Method Of Administration

The intramuscular route is the preferred choice for most individuals who have to be given adrenaline for the management of an anaphylactic reaction.

The following adrenaline doses are advised by the Working Group of the Resuscitation Council (UK).

Dose of intramuscular injection of Adrenaline (Epinephrine) Injection BP 1 in 1000 for a severe anaphylactic reaction
Age	Dose	Volume of adrenaline 1 in 1000 (1mg/ml)
Child under 6 years	150 micrograms	0.15 ml 1
Child 6 – 12 years	300 micrograms	0.3 ml
Child> 12 years	500 micrograms	0.5 ml 2
Adult	500 micrograms	0.5 ml
These doses may be repeated several times if necessary at 5 – minute intervals according to blood pressure, pulse, and respiratory function.

1. Use suitable syringe for measuring small volume

2. 300 micrograms (0.3ml) if child is small or prepubertal

There is lack of robust evidence for the doses recommended in children: the recommended doses are based on what is considered to be safe and practical.

4.3 Contraindications

Hypersensitivity to adrenaline, sodium metabisulphite or any of the other ingredients.

Adrenaline 1 in 1000 should not be used in fingers, toes, ears, nose or genitalia owing to the risk of ischaemic tissue necrosis.

4.4 Special Warnings And Precautions For Use

Adrenaline should be used with caution in patients with hyperthyroidism, diabetes mellitus, phaeochromocytoma, narrow angle glaucoma, hypokalaemia, hypercalcaemia, severe renal impairment, prostatic adenoma leading to residual urine, cerebrovascular disease, organic brain damage or arteriosclerosis, in elderly patients, in patients with shock (other than anaphylactic shock) and in organic heart disease or cardiac dilatation (severe angina pectoris, obstructive cardiomyopathy, hypertension) as well as most patients with arrhythmias. Anginal pain may be induced when coronary insufficiency is present.

Adrenaline should be used cautiously, if at all, during general anaesthesia with halogenated hydrocarbon anaesthetics (See section 4.5).

Adrenaline should not be used during the second stage of labour (See Section 4.6).

Accidental intravascular injection may result in cerebral haemorrhage due to the sudden rise in blood pressure.

Adrenaline 1 in 1000 should not be diluted to 1 in 10,000 for use in cardiac resuscitation - when the 1 in 10,000 strength of adrenaline is required for this indication a “ready to use” preparation should be selected.

Monitor the patient as soon as possible (pulse, blood pressure, ECG, pulse oximetry) in order to assess the response to adrenaline.

The best site for IM injection is the anterolateral aspect of the middle third of the thigh. The needle used for injection needs to be sufficiently long to ensure that the adrenaline is injected into muscle. Intramuscular injections of Adrenaline into the buttocks should be avoided because of the risk of tissue necrosis.

Prolonged use of Adrenaline can result in severe metabolic acidosis because of elevated blood concentrations of lactic acid.

Adrenaline Injection contains sodium metabisulphite, which can cause allergic-type reactions, including anaphylaxis and life-threatening or less severe asthmatic episodes, in certain susceptible individuals.

The presence of sodium metabisulphite in parenteral Adrenaline and the possibility of allergic-type reactions should not deter use of the drug when indicated for the treatment of serious allergic reactions or for other emergency situations.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Sympathomimetic agents:

Adrenaline should not be administered concomitantly with other sympathomimetic agents because of the possibility of additive effects and increased toxicity.

Alpha-adrenergic blocking agents:

Alpha-blockers such as phentolamine antagonise the vasoconstriction and hypertension effects of adrenaline. This effect may be beneficial in adrenaline overdose (See section 4.9).

Beta-adrenergic blocking agents:

Severe hypertension and reflex bradycardia may occur with non-cardioselective beta-blocking agents such as propranolol, due to alpha-mediated vasoconstriction.

Beta-blockers, especially non-cardioselective agents, also antagonise the cardiac and bronchodilator effects of adrenaline. Patients with severe anaphylaxis who are taking non-cardioselective beta-blockers may not respond to adrenaline treatment.

General Anaesthetics:

Administration of Adrenaline in patients receiving halogenated hydrocarbon general anaesthetics that increase cardiac irritability and seem to sensitise the myocardium to Adrenaline may result in arrhythmias including ventricular premature contractions, tachycardia or fibrillation (See section 4.4).

Antihypertensive agents:

Adrenaline specifically reverses the antihypertensive effects of adrenergic neurone blockers such as guanethidine, with the risk of severe hypertension. Adrenaline increases blood pressure and may antagonise the effects of antihypertensive drugs.

Antidepressant agents:

Tricyclic antidepressants such as imipramine inhibit reuptake of directly acting sympathomimetic agents, and may potentiate the effect of adrenaline, increasing the risk of development of hypertension and cardiac arrhythmias.

Although monoamine oxidase (MAO) is one of the enzymes responsible for Adrenaline metabolism, MAO inhibitors do not markedly potentiate the effects of Adrenaline.

Phenothiazines:

Phenothiazines block alpha-adrenergic receptors (see above).

Adrenaline should not be used to counteract circulatory collapse or hypotension caused by phenothiazines; a reversal of the pressor effects of Adrenaline may result in further lowering of blood pressure.

Other drugs:

Adrenaline should not be used in patients receiving high dosage of other drugs (e.g. cardiac glycosides) that can sensitise the heart to arrhythmias. Some antihistamines (e.g. diphenhydramine) and thyroid hormones may potentiate the effects of Adrenaline, especially on heart rhythm and rate.

Hypokalaemia:

The hypokalaemic effect of adrenaline may be potentiated by other drugs that cause potassium loss, including corticosteroids, potassium-depleting diuretics, aminophylline and theophylline.

Hyperglycaemia:

Adrenaline-induced hyperglycaemia may lead to loss of blood-sugar control in diabetic patients treated with insulin or oral hypoglycaemic agents.

4.6 Pregnancy And Lactation

Adrenaline usually inhibits spontaneous or oxytocin induced contractions of the pregnant human uterus and may delay the second stage of labour. In dosage sufficient to reduce uterine contractions, the drug may cause a prolonged period of uterine atony with haemorrhage. If used during pregnancy, Adrenaline may cause anoxia to the foetus. For this reason parenteral Adrenaline should not be used during the second stage of labour. Adrenaline should only be used during pregnancy if the potential benefits justify the possible risks to the foetus.

Adrenaline is distributed into breast milk. Breast-feeding should be avoided in mothers receiving Adrenaline injection.

4.7 Effects On Ability To Drive And Use Machines

None noted.

4.8 Undesirable Effects

The adverse events of adrenaline mainly relate to the stimulation of both alpha- and beta-adrenergic receptors. The occurrence of undesirable effects depends on the sensitivity of the individual patient and the dose involved.

Immune system disorders:

Anaphylaxis, possibly with severe bronchospasm (See section 4.4).

Metabolism and nutrition disorders:

Hyperglycaemia, hypokalaemia, metabolic acidosis (see section 4.4).

Psychiatric disorders:

Anxiety

Nervous system disorders

Headache, dizziness, tremors

In patients with Parkinsonian Syndrome, Adrenaline increases rigidity and tremor.

Subarachnoid haemorrhage and hemiplegia have resulted from hypertension, even following subcutaneous administration of usual doses of Adrenaline.

Cardiac disorders:

Disturbances of cardiac rhythm and rate may result in palpitation and tachycardia. Chest pain/angina may occur. Adrenaline can cause potentially fatal ventricular arrhythmias including fibrillation, especially in patients with organic heart disease or those receiving other drugs that sensitise the heart to arrhythmias.

Adrenaline causes E.C.G. changes including a decrease in T-Wave amplitude in all leads in normal subjects.

Vascular disorders:

Hypertension (with risk of cerebral haemorrhage).

Coldness of extremities may occur even with small doses of Adrenaline.

Respiratory disorders:

Pulmonary oedema may occur after excessive doses or in extreme sensitivity.

Gastrointestinal disorders:

Nausea, vomiting.

Renal and urinary disorders:

Difficulty in micturition, urinary retention.

General disorders and administrative site conditions:

Sweating, weakness.

Repeated injections of Adrenaline can cause necrosis as a result of vascular constriction at the injection site. Tissue necrosis may also occur in the extremities, kidneys and liver.

4.9 Overdose

Symptoms

After overdosage or inadvertent intravenous administration of usual intramuscular subcutaneous doses of Adrenaline, systolic and diastolic blood pressure rise sharply; venous pressure also rises. Cerebrovascular or other haemorrhages and hemiplegia may result, especially in elderly patients. Pulmonary oedema may occur.

Adrenaline overdosage causes transient bradycardia followed by tachycardia and may cause other potentially fatal cardiac arrhythmias. Kidney failure, metabolic acidosis and cold white skin may also occur.

Treatment

Because Adrenaline is rapidly inactivated in the body, treatment of acute toxicity is mainly supportive.

The pressor effects of Adrenaline may be counteracted by an immediate intravenous injection of a quick-acting alpha-adrenoreceptor blocking agent, such as 5-10 mg of phentolamine mesylate, followed by a beta-adrenoreceptor blocking agent, such as 2.5 - 5 mg of propranolol. Arrhythmias, if they occur, may be counteracted by propranolol injection.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: adrenergic and dopaminergic agents, adrenaline.

ATC code: C01 CA 24

Adrenaline is a naturally occurring catecholamine secreted by the adrenal medulla in response to exertion or stress. It is a sympathomimetic amine which is a potent stimulant of both alpha- and beta-adrenergic receptors and its effects on target organs are therefore complex. It is used to provide rapid relief of hypersensitivity reactions to allergies or to idiopathic or exercise-induced anaphylaxis.

Adrenaline has a strong vasoconstrictor action through alpha- adrenergic stimulation. This activity counteracts the vasodilatation and increased vascular permeability leading to loss of intravascular fluid and subsequent hypotension, which are the major pharmacological features in anaphylactic shock.

Adrenaline stimulates bronchial beta-adrenergic receptors and has a powerful bronchodilator action. Adrenaline also alleviates pruritus, urticaria and angioedema associated with anaphylaxis.

5.2 Pharmacokinetic Properties

Adrenaline has a rapid onset of action after intramuscular administration and in the shocked patient its absorption from the intramuscular site is faster and more reliable than from the subcutaneous site.

Adrenaline is rapidly inactivated in the body, mostly in the liver by the enzymes catechol-O-methyltransferase (COMT) and monoamine oxidase (MAO). Much of a dose of adrenaline is excreted as metabolites in urine. The plasma half-life is about 2-3 minutes. However, when given by subcutaneous or intramuscular injection, local vasoconstriction may delay absorption so that the effects may last longer than the half-life suggests.

5.3 Preclinical Safety Data

No further information other than that which is included in the Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium Metabisulphite Ph. Eur.

Sodium Chloride Ph. Eur.

Sodium Hydroxide Ph. Eur.

Water for Injections Ph. Eur.

Hydrochloric Acid Ph. Eur.

6.2 Incompatibilities

Adrenaline is rapidly denatured by oxidising agents and alkalis including sodium bicarbonate, halogens, nitrates, nitrites and salts of iron, copper and zinc. Adrenaline may be mixed with 0.9% Sodium Chloride injection but is incompatible with 5% sodium chloride injection. The stability of Adrenaline in 5% dextrose injection decreases when the pH is greater than 5.5.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Store at less than 25 C and protect from light.

6.5 Nature And Contents Of Container

Clear glass ampoules of 1 ml. Packed in cardboard cartons to contain 10 ampoules x 1 ml.

6.6 Special Precautions For Disposal And Other Handling

Use as directed by the Physician.

ADMINISTRATIVE DATA

7. Marketing Authorisation Holder

hameln pharmaceuticals ltd

Gloucester

UK

8. Marketing Authorisation Number(S)

PL 01502/0024

9. Date Of First Authorisation/Renewal Of The Authorisation

14^th December 1978 / 23^rd August 2001

10. Date Of Revision Of The Text

06/08/09

Citracal Maximum + D

Generic Name: calcium and vitamin D combination (KAL see um and VYE ta min D)

Brand Names: Calcarb with D, Calcet, Calcio Del Mar, Calcitrate with D, Calcium 600+D, Caltrate 600 with D, Caltrate 600 with D Plus Soy, Caltrate Colon Health, Citracal + D, Citracal 250 mg + D, Citracal Creamy Bites, Citracal Maximum + D, Citracal Petites, Citrus Calcium with Vitamin D, Dical-D, Os-Cal 250 with D, Os-Cal 500 + D, Os-Cal with D, Oysco 500 with D, Oysco D, Oyst-Cal-D, Oyster Shell Calcium with Vitamin D, Oyster-D, Oystercal-D, Posture-D H/P, Risacal-D

What is Citracal Maximum + D (calcium and vitamin D combination)?

Calcium is a mineral that is found naturally in foods. Calcium is necessary for many normal functions of your body, especially bone formation and maintenance.

Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Calcium and vitamin D combination is used to prevent or to treat a calcium deficiency.

Calcium and vitamin D combination may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Citracal Maximum + D (calcium and vitamin D combination)?

Before you take calcium and vitamin D combination, tell your doctor if you have kidney disease, past or present kidney stones, heart disease, circulation problems, a parathyroid disorder, or if you are pregnant or breast-feeding.

Avoid taking any other vitamin or mineral supplements that contain calcium or vitamin D without first talking to your doctor.

Before taking calcium and vitamin D combination, tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

What should I tell my healthcare provider before taking Citracal Maximum + D (calcium and vitamin D combination)?

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take calcium and vitamin D combination, tell your doctor if you have:

• kidney disease;


• past or present kidney stones;


• 
  

  heart disease;

  
  


• 
  

  circulation problems; or

  
  


• 
  

  a parathyroid gland disorder.

  
  

Talk to your doctor before taking calcium and vitamin D combination if you are pregnant. Talk to your doctor before taking calcium and vitamin D combination if you are breast-feeding.

How should I take Citracal Maximum + D (calcium and vitamin D combination)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take the calcium and vitamin D regular tablet with a full glass of water.

The chewable tablet should be chewed before you swallow it.

Store calcium and vitamin D combination at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include irregular heartbeat, stomach pain, nausea, vomiting, dry mouth, a metallic taste in your mouth, confusion, loss of appetite, constipation, weakness, headache, confusion, or fainting.

What should I avoid while taking Citracal Maximum + D (calcium and vitamin D combination)?

Avoid taking any other vitamin or mineral supplements that contain calcium or vitamin D without first talking to your doctor.

Citracal Maximum + D (calcium and vitamin D combination) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

• 
  

  an irregular heartbeat;

  
  


• 
  

  nausea, vomiting, or decreased appetite;

  
  


• 
  

  dry mouth;

  
  


• 
  

  constipation;

  
  


• 
  

  weakness;

  
  


• 
  

  headache;

  
  


• 
  

  a metallic taste;

  
  


• 
  

  muscle or bone pain; or

  
  


• 
  

  drowsiness.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Citracal Maximum + D (calcium and vitamin D combination)?

Before taking calcium and vitamin D combination, tell your doctor if you are taking:

• 
  

  digoxin (Lanoxin, Lanoxicaps);

  
  


• 
  

  antacids containing calcium, aluminum, or magnesium;

  
  


• 
  

  other calcium supplements;

  
  


• 
  

  calcitriol (Rocaltrol) or other vitamin D supplements; or

  
  


• 
  

  a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

  
  

This list is not complete and there may be other drugs that can interact with calcium and vitamin D combination. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Citracal Maximum + D resources

• Citracal Maximum + D Side Effects (in more detail)
• Citracal Maximum + D Use in Pregnancy & Breastfeeding
• Citracal Maximum + D Drug Interactions
• Citracal Maximum + D Support Group
• 0 Reviews for Citracal Maximum + D - Add your own review/rating

Compare Citracal Maximum + D with other medications

• Dietary Supplementation
• Osteoporosis

Where can I get more information?

• Your pharmacist can provide more information about calcium and vitamin D combination.

See also: Citracal Maximum + D side effects (in more detail)

neomycin/polymyxin B and dexamethasone ophthalmic

Generic Name: neomycin, polymyxin B, and dexamethasone ophthalmic (NEE oh MYE sin, POL ee MIX in DEX a METH a sone off THAL mik)

Brand names: Maxitrol, Ocu-Trol, Poly-Dex, Dexacidin, Dexasporin, Methadex, AK-Trol, Dexacine

What is neomycin, polymyxin B and dexamethasone ophthalmic?

Neomycin and polymyxin B are antibiotics. They are used to treat bacterial infections.

Dexamethasone is a steroid. It is used to treat the swelling associated with bacterial infections of the eye.

Neomycin, polymyxin B and dexamethasone ophthalmic is used to treat bacterial infections of the eyes.

Neomycin, polymyxin B and dexamethasone ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about neomycin, polymyxin B and dexamethasone ophthalmic?

Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear duct.

Who should not use neomycin, polymyxin B and dexamethasone ophthalmic?

Do not use neomycin, polymyxin B and dexamethasone ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only. It is not known whether neomycin, polymyxin B and dexamethasone ophthalmic will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is not known whether neomycin, polymyxin B and dexamethasone ophthalmic passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

How should I use neomycin, polymyxin B and dexamethasone ophthalmic?

Use neomycin, polymyxin B and dexamethasone eyedrops or ointment exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using your eyedrops or ointment.

To apply the eyedrops:

• 
  

  Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.

  
  

To apply the ointment:

• 
  

  Hold the tube in your hand for a few minutes to warm it up so that the ointment comes out easily. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around in all directions for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before your next application.

  
  

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.

Never use any eyedrop that is discolored or has particles in it.

Store neomycin, polymyxin B and dexamethasone ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube properly capped.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops or ointment have been ingested, drink plenty of fluid and call an emergency center for advice.

What should I avoid while using neomycin, polymyxin B and dexamethasone ophthalmic?

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Use caution when driving, operating machinery, or performing other hazardous activities. Neomycin, polymyxin B and dexamethasone ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

Use caution with contact lenses. Wear them only if your doctor approves. After applying this medication, wait at least 15 minutes before inserting contact lenses.

Avoid other eye medications unless your doctor approves.

Neomycin, polymyxin B and dexamethasone ophthalmic side effects

Serious side effects are not expected with this medication.

Some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Neomycin, polymyxin B, and dexamethasone ophthalmic Dosing Information

Usual Adult Dose for Uveitis:

Steroid responsive inflammatory ocular conditions with superficial bacterial infection or risk of infection:
Suspension:
Severe: Instill 1 to 2 drops in the conjunctival sac of the affected eye(s) up to once every hour. Taper to discontinuation as inflammation subsides.
Mild: Instill 1 to 2 drops in the conjunctival sac of the affected eye(s) 4 to 6 times daily.

Ointment: Apply small amount (1/2 inch ribbon) into conjunctival sac of the affected eye(s) up to 3 to 4 times daily.

Usual Adult Dose for Bacterial Conjunctivitis:

Steroid responsive inflammatory ocular conditions with superficial bacterial infection or risk of infection:
Suspension:
Severe: Instill 1 to 2 drops in the conjunctival sac of the affected eye(s) up to once every hour. Taper to discontinuation as inflammation subsides.
Mild: Instill 1 to 2 drops in the conjunctival sac of the affected eye(s) 4 to 6 times daily.

Ointment: Apply small amount (1/2 inch ribbon) into conjunctival sac of the affected eye(s) up to 3 to 4 times daily.

Usual Adult Dose for Keratitis:

Steroid responsive inflammatory ocular conditions with superficial bacterial infection or risk of infection:
Suspension:
Severe: Instill 1 to 2 drops in the conjunctival sac of the affected eye(s) up to once every hour. Taper to discontinuation as inflammation subsides.
Mild: Instill 1 to 2 drops in the conjunctival sac of the affected eye(s) 4 to 6 times daily.

Ointment: Apply small amount (1/2 inch ribbon) into conjunctival sac of the affected eye(s) up to 3 to 4 times daily.

Usual Adult Dose for Keratoconjunctivitis:

Steroid responsive inflammatory ocular conditions with superficial bacterial infection or risk of infection:
Suspension:
Severe: Instill 1 to 2 drops in the conjunctival sac of the affected eye(s) up to once every hour. Taper to discontinuation as inflammation subsides.
Mild: Instill 1 to 2 drops in the conjunctival sac of the affected eye(s) 4 to 6 times daily.

Ointment: Apply small amount (1/2 inch ribbon) into conjunctival sac of the affected eye(s) up to 3 to 4 times daily.

Usual Adult Dose for Blepharitis:

Steroid responsive inflammatory ocular conditions with superficial bacterial infection or risk of infection:
Suspension:
Severe: Instill 1 to 2 drops in the conjunctival sac of the affected eye(s) up to once every hour. Taper to discontinuation as inflammation subsides.
Mild: Instill 1 to 2 drops in the conjunctival sac of the affected eye(s) 4 to 6 times daily.

Ointment: Apply small amount (1/2 inch ribbon) into conjunctival sac of the affected eye(s) up to 3 to 4 times daily.

What other drugs will affect neomycin, polymyxin B and dexamethasone ophthalmic?

Avoid other eye medications unless they are approved by your doctor.

Before using this medication, tell your doctor if you are taking an oral steroid medication such as prednisone (Deltasone, Orasone, others).

Drugs other than those listed here may also interact with neomycin, polymyxin B and dexamethasone ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More neomycin, polymyxin B, and dexamethasone ophthalmic resources

• Neomycin, polymyxin B, and dexamethasone ophthalmic Side Effects (in more detail)
• Neomycin, polymyxin B, and dexamethasone ophthalmic Use in Pregnancy & Breastfeeding
• Neomycin, polymyxin B, and dexamethasone ophthalmic Drug Interactions
• Neomycin, polymyxin B, and dexamethasone ophthalmic Support Group
• 0 Reviews for Neomycin, polymyxin B, and dexamethasone - Add your own review/rating

Compare neomycin, polymyxin B, and dexamethasone ophthalmic with other medications

• Blepharitis
• Conjunctivitis, Bacterial
• Keratitis
• Keratoconjunctivitis
• Uveitis

Where can I get more information?

• Your pharmacist has additional information about neomycin, polymyxin B and dexamethasone written for health professionals that you may read.

See also: neomycin, polymyxin B, and dexamethasone side effects (in more detail)

Eprosartan

Pronunciation: EP-roe-SAR-tan
Generic Name: Eprosartan
Brand Name: Teveten

Eprosartan may cause injury or death to the fetus if taken during pregnancy. If you think you may be pregnant, contact your doctor right away.

Eprosartan is used for:

Treating high blood pressure alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Eprosartan is an angiotensin II receptor blocker (ARB). It works by relaxing blood vessels. This helps to lower blood pressure.

Do NOT use Eprosartan if:

• you are allergic to any ingredient in Eprosartan


• you are pregnant

Contact your doctor or health care provider right away if any of these apply to you.

Before using Eprosartan:

Some medical conditions may interact with Eprosartan. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are able to become pregnant


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of angioedema (eg, swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; hoarseness), including angioedema caused by treatment with an angiotensin-converting enzyme (ACE) inhibitor (eg, lisinopril)


• if you have a history of heart problems (eg, heart failure), blood vessel problems, blood flow problems, or kidney problems


• if you have a history of stroke or a recent heart attack


• if you are dehydrated or have low blood volume


• if you have electrolyte problems (eg, high blood potassium levels, low blood sodium levels) or are on a low-salt (sodium) diet


• if you have diabetes, especially if you are also taking aliskiren


• if you are on dialysis or are scheduled to have major surgery

Some MEDICINES MAY INTERACT with Eprosartan. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood pressure may be increased


• ACE inhibitors (eg, lisinopril) because the risk of kidney problems and high blood potassium levels may be increased


• Aliskiren, potassium-sparing diuretics (eg, spironolactone, triamterene), or potassium supplements because the risk of high blood potassium levels may be increased


• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, celecoxib, ibuprofen, indomethacin) because they may decrease Eprosartan's effectiveness and the risk of kidney problems may be increased


• Lithium because the risk of its side effects may be increased by Eprosartan

This may not be a complete list of all interactions that may occur. Ask your health care provider if Eprosartan may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Eprosartan:

Use Eprosartan as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Eprosartan by mouth with or without food.


• Take Eprosartan on a regular schedule to get the most benefit from it. Taking Eprosartan at the same time each day will help you remember to take it.


• Continue to take Eprosartan even if you feel well. Do not miss any doses.


• If you miss a dose of Eprosartan, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Eprosartan.

Important safety information:

• Eprosartan may cause dizziness, light-headedness, or fainting. These effects may be worse if you take it with alcohol or certain medicines. Use Eprosartan with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Eprosartan may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Eprosartan may cause a serious side effect called angioedema. Contact your doctor at once if you develop swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness.


• Dehydration, excessive sweating, vomiting, or diarrhea may increase the risk of low blood pressure. Contact your health care provider at once if any of these occur.


• Check with your doctor before you use a salt substitute or a product that has potassium in it.


• Tell your doctor or dentist that you take Eprosartan before you receive any medical or dental care, emergency care, or surgery.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Eprosartan may not work as well in black patients. Discuss any questions or concerns with your doctor.


• If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.


• Lab tests, including blood pressure, blood electrolyte levels, and heart, kidney, or liver function, may be performed while you take Eprosartan. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Eprosartan should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Eprosartan may cause birth defects or fetal death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Eprosartan is found in breast milk. Do not breast-feed while taking Eprosartan.

Possible side effects of Eprosartan:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; upper respiratory tract infection.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; hoarseness); change in the amount of urine produced; chest pain; difficulty swallowing; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; muscle pain or cramps; swelling of the hands, ankles, or feet; symptoms of low blood pressure (eg, fainting, light-headedness, severe dizziness); unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Eprosartan side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Eprosartan:

Store Eprosartan between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Eprosartan out of the reach of children and away from pets.

General information:

• If you have any questions about Eprosartan, please talk with your doctor, pharmacist, or other health care provider.


• Eprosartan is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Eprosartan. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Eprosartan resources

• Eprosartan Side Effects (in more detail)
• Eprosartan Dosage
• Eprosartan Use in Pregnancy & Breastfeeding
• Drug Images
• Eprosartan Drug Interactions
• Eprosartan Support Group
• 0 Reviews for Eprosartan - Add your own review/rating

• Eprosartan Prescribing Information (FDA)


• eprosartan Advanced Consumer (Micromedex) - Includes Dosage Information


• eprosartan Concise Consumer Information (Cerner Multum)


• Eprosartan Mesylate Monograph (AHFS DI)


• Teveten Prescribing Information (FDA)

Compare Eprosartan with other medications

• High Blood Pressure

Xarelto 10 mg film-coated tablets

Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.

If you have any doubts or queries about your medication, please contact your doctor or pharmacist.

Xarelto 10 mg film-coated tablets

Rivaroxaban

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor
  or pharmacist.

In this leaflet:

1. What Xarelto is and what it is used for

2. Before you take Xarelto

3. How to take Xarelto

4. Possible side effects

5. How to store Xarelto

6. Further information

What Xarelto Is And What It Is Used For

Xarelto is used to prevent blood clots in your veins after a hip or knee replacement operation. Your doctor has prescribed this medicine for you because after an operation you are at an increased risk of getting blood clots.

Xarelto belongs to a group of medicines called antithrombotic agents. It works by blocking a blood clotting factor (factor Xa) and thus reducing the tendency of the blood to form clots.

Before You Take Xarelto

Do not take Xarelto

• 
  if you are allergic (hypersensitive) to rivaroxaban or any of the other ingredients of Xarelto.
  
  The ingredients are listed at the end of this leaflet


• 
  if you are bleeding excessively
  


• 
  if you have a liver disease which leads to an increased risk of bleeding


• 
  if you are pregnant or breast-feeding
  

Do not take Xarelto and tell your doctor if any of these apply to you.

Take special care with Xarelto

• if you have moderate or severe kidney disease


• if you have moderate liver disease


• if you have an increased risk of bleeding such as:
  
  
  • bleeding disorders
  • very high blood pressure, not controlled by medical treatment
  • active ulcer or a recent ulcer of your stomach or bowel
  • a problem with the blood vessels in the back of your eyes (retinopathy)
  • recent bleeding in your brain (intracranial or intracerebral bleeding)
  • problems with the blood vessels in your brain or spinal column
  • a recent operation on your brain, spinal column or eye

Tell your doctor before you take Xarelto, if any of these apply to you. Your doctor will decide, if you should be treated with Xarelto and if you should be kept under closer observation.

• Xarelto is not recommended after an operation of a hip fracture.


• 
  in children and adolescents, Xarelto is not recommended for people under 18 years of age. There is not enough information on its use in children and adolescents.


• 
  if your operation involves a catheter or injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction):
  
  
  • it is very important to take Xarelto before and after the injection or removal of the catheter exactly at the times you have been told by your doctor
  • tell your doctor immediately if you get numbness or weakness of your legs or problems with your bowel or bladder after the end of anaesthesia, because urgent care is necessary.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

• 
  If you are taking:
  
  • some medicines for fungal infections (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole), unless they are only applied to the skin
  
  
  • some anti-viral medicines for HIV / AIDS (e.g. ritonavir)
  
  
  • other medicines to reduce blood clotting (e.g. enoxaparin or clopidogrel)
  
  
  • 
    anti-inflammatory and pain relieving medicines (e.g. naproxen or acetylsalicylic acid)
    
  
  
  Tell your doctor before taking Xarelto, because its effect may be increased. Your doctor will decide, if you should be treated with Xarelto and if you should be kept under closer observation.
  


• 
  If you are taking:
  
  • some medicines for treatment of epilepsy (phenytoin, carbamazepine, phenobarbital),
  
  
  • 
    St Johns Wort, a herbal product used for depression,
  
  
  • 
    rifampicin, an antibiotic.
  
  
  Tell your doctor before taking Xarelto, because its effect may be reduced. Your doctor will decide, if you should be treated with Xarelto and if you should be kept under closer observation.
  

Taking Xarelto with food and drink

Xarelto can be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding do not take Xarelto. If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking Xarelto. If you become pregnant while you are taking Xarelto, immediately tell your doctor, who will decide how you should be treated.

Driving and using machines

No studies on the effects of Xarelto on the ability to drive and use machines have been performed. However, Xarelto may cause side effects such as dizziness or fainting. You should not drive or use machines if you are affected by these symptoms. For Xarelto, these side effects are uncommon (see section 4 “Possible side effects”).

Important information about some of the ingredients of Xarelto

Xarelto contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Xarelto.

How To Take Xarelto

Always take Xarelto exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much to take

The usual dose is one tablet (10 mg) once a day.

Swallow the tablet preferably with water.

Xarelto can be taken with or without food.

When to take Xarelto

Take the first tablet 6 - 10 hours after your operation.

Then take a tablet every day until your doctor tells you to stop.

Try to take the tablet at the same time every day to help you to remember it.

If you have had a major hip operation you will usually take the tablets for 5 weeks.

If you have had a major knee operation you will usually take the tablets for 2 weeks.

If you take more Xarelto than you should

Contact your doctor immediately if you have taken too many Xarelto tablets. Taking too much Xarelto increases the risk of bleeding.

If you forget to take Xarelto

If you have missed a dose, take it as soon as you remember. Take the next tablet on the following day and then carry on taking a tablet once a day as normal.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Xarelto

Don’t stop taking Xarelto without talking to your doctor first, because Xarelto prevents the development of a serious condition.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Xarelto can cause side effects, although not everybody gets them.

Like other similar medicines (antithrombotic agents), Xarelto may cause bleedings which may potentially be life threatening. In some cases these bleedings may not be obvious.

Tell your doctor, if you experience any of the following side effects:

• 
  long or excessive bleeding
  


• 
  exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling.
  

Your doctor may decide to keep you under closer observation or change how you should be treated.

The frequency of possible side effects listed below is defined using the following convention:

very common (affects more than 1 user in 10)

common (affects 1 to 10 users in 100)

uncommon (affects 1 to 10 users in 1,000)

rare (affects 1 to 10 users in 10,000)

very rare (affects less than 1 user in 10,000)

not known (frequency cannot be estimated from the available data).

Common side effects

• bleeding following your operation


• reduction in red blood cells which can make your skin pale and cause weakness or breathlessness


• feeling sick


• blood tests may show an increase in some liver enzymes

Uncommon side effects

• bleeding in your stomach or bowel, genital bleeding, nose bleed


• bleeding into tissue or a cavity of your body (haematoma, bruising)


• blood in your urine


• oozing of blood or fluid from surgical wound


• raised heartbeat


• low blood pressure


• feeling unwell (weakness, tiredness), headache, dizziness, fainting


• stomach ache, indigestion, constipation, diarrhoea, being sick


• dry mouth


• localised swelling, swelling in your limbs


• fever


• pain in your limbs


• rash, itchy skin, hives


• impaired function of your kidneys


• blood tests may show an increase in bilirubin, some pancreatic enzymes or in the number of platelets

Rare side effects

• impaired function of your liver


• allergic skin reactions

Side effects where frequency is not known

• bleeding into a critical organ (e.g. your brain)


• adrenal bleeding


• bleeding from the whites of your eyes


• coughing up blood


• yellowing of the skin and eye (jaundice)


• hypersensitivity

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Xarelto

Keep out of the reach and sight of children.

Do not use Xarelto after the expiry date which is stated on the carton and on each blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Xarelto contains

• The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.


• The other ingredients are:
  
  Tablet core: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose, sodium laurilsulfate, magnesium stearate.
  
  Film coat: macrogol 3350, hypromellose, titanium dioxide (E171), iron oxide red (E172).

What Xarelto looks like and contents of the pack

The film-coated tablets are light red, round and marked with the BAYER-cross on one side and "10" and a triangle on the other side. They come in blisters in cartons of 5, 10 or 30 tablets or unit dose blisters in cartons of 10 x 1 or 100 x 1 tablets.

Not all pack-sizes may be marketed.

Marketing Authorisation Holder

Bayer Schering Pharma AG

13342 Berlin

Germany

Manufacturer

Bayer Schering Pharma AG

51368 Leverkusen

Germany

For more information about this medicine, please contact the local representative of the Marketing Authorisation Holder

United Kingdom

Bayer plc

Tel:+44-(0)1635-563000

This leaflet was last approved in {06/2010}

Tarceva

Generic Name: erlotinib (er LOE ti nib)

Brand Names: Tarceva

What is erlotinib?

Erlotinib is a cancer medication that interferes with the growth of cancer cells and slows their spread in the body.

Erlotinib is used to treat non-small cell lung cancer. Erlotinib is also used in combination with other cancer medicine to treat pancreatic cancer.

Erlotinib may also be used for purposes not listed in this medication guide.

What is the most important information I should know about erlotinib?

Do not take erlotinib if you are pregnant. It could harm the unborn baby. Use effective birth control while you are taking this medication and for at least 2 weeks after your treatment ends.

Before taking erlotinib, tell your doctor if you have lung problems (other than lung cancer), kidney or liver disease, if you are dehydrated, or if you smoke.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. This will help your doctor determine how long to treat you with erlotinib. Visit your doctor regularly.

Avoid exposure to sunlight or tanning beds. Erlotinib can cause skin rash, dryness, or other irritation. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Avoid using skin products that can cause dryness or irritation. Stop taking erlotinib and call your doctor at once if you have new or worsening lung problems (chest pain, dry cough with fever, wheezing, feeling short of breath), chest pain spreading to the arm or shoulder, sudden numbness or weakness, eye pain or irritation, rapid weight gain, urinating less than usual or not at all, severe or ongoing diarrhea or vomiting, coughing up blood, black or bloody stools, pale skin, easy bruising or bleeding, mouth sores, or a severe skin rash. There are many other drugs that can interact with erlotinib. Tell your doctor about all medications you use. Keep a list of all your medicines and show it to any healthcare provider who treats you.

What should I discuss with my healthcare provider before taking erlotinib?

You should not take erlotinib if you are allergic to it.

If you have any of these other conditions, you may need a dose adjustment or special tests:

• 
  

  lung or breathing problems (other than lung cancer);

  
  


• 
  

  kidney disease;

  
  


• 
  

  liver disease;

  
  


• 
  

  if you are dehydrated; or

  
  


• 
  

  if you smoke.

  
  

FDA pregnancy category D. Do not take erlotinib if you are pregnant. It could harm the unborn baby. Use effective birth control while you are taking this medication and for at least 2 weeks after your treatment ends. It is not known whether erlotinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while taking erlotinib.

How should I take erlotinib?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Take erlotinib on an empty stomach, at least 1 hour before or 2 hours after eating. Do not crush an erlotinib tablet. The medicine from a crushed or broken pill can be dangerous if it gets on your skin. If this occurs, wash your skin with soap and water and rinse thoroughly.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. This will help your doctor determine how long to treat you with erlotinib. Visit your doctor regularly.

Store at room temperature away from moisture and heat.

See also: Tarceva dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember (take only on an empty stomach). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe diarrhea, severe skin rash, dark urine, stomach pain, or jaundice (yellowing of your skin or eyes).

What should I avoid while using erlotinib?

Avoid taking an antacid within several hours before or after you take erlotinib. Avoid exposure to sunlight or tanning beds. Erlotinib can cause skin rash, dryness, or other irritation. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid using skin products that can cause dryness or irritation, such as acne medications, harsh soaps or skin cleansers, or skin products that contain alcohol.

Avoid smoking. It can make erlotinib less effective.

Grapefruit and grapefruit juice may interact with erlotinib and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Erlotinib side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop taking erlotinib and call your doctor at once if you have a serious side effect such as:

• 
  

  new or worsening lung problems such as chest pain, dry cough with fever, wheezing, rapid breathing, feeling short of breath;

  
  


• 
  

  chest pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  sudden numbness or weakness, sudden severe headache, or problems with vision, speech, or balance;

  
  


• 
  

  eye pain, redness, or irritation;

  
  


• 
  

  confusion, mood changes, increased thirst, urinating less than usual or not at all;

  
  


• 
  

  swelling, rapid weight gain;

  
  


• 
  

  severe or ongoing diarrhea, vomiting, or loss of appetite;

  
  


• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  pale or yellowed skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  
  


• 
  

  white patches or sores inside your mouth or on your lips;

  
  


• 
  

  fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

  
  


• 
  

  the first sign of any type of skin rash, no matter how mild; or

  
  


• 
  

  nausea, upper stomach pain, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  mild stomach upset, nausea, or diarrhea;

  
  


• 
  

  weight loss;

  
  


• 
  

  acne, dry skin; or

  
  


• 
  

  tired feeling.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect erlotinib?

Many drugs can interact with erlotinib. Below is just a partial list. Tell your doctor if you are using:

• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  bosentan (Tracleer);

  
  


• 
  

  conivaptan (Vaprisol);

  
  


• 
  

  dexamethasone (Decadron, Hexadrol);

  
  


• 
  

  imatinib (Gleevec);

  
  


• 
  

  isoniazid (for treating tuberculosis);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  steroid medicine (prednisone and others);

  
  


• 
  

  an antibiotic such as ciprofloxacin (Cipro), clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), or telithromycin (Ketek);

  
  


• 
  

  an antidepressant such as nefazodone;

  
  


• 
  

  antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);

  
  


• 
  

  a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);

  
  


• 
  

  heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

  
  


• 
  

  HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), or saquinavir (Invirase);

  
  


• 
  

  medicines to treat narcolepsy, such as armodafanil (Nuvigil) or modafanil (Progivil);

  
  


• 
  

  NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin, ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others; or

  
  


• 
  

  seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

  
  

This list is not complete and there are many other drugs that can interact with erlotinib. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More Tarceva resources

• Tarceva Side Effects (in more detail)
• Tarceva Dosage
• Tarceva Use in Pregnancy & Breastfeeding
• Drug Images
• Tarceva Drug Interactions
• Tarceva Support Group
• 11 Reviews for Tarceva - Add your own review/rating

• Tarceva Prescribing Information (FDA)


• Tarceva Monograph (AHFS DI)


• Tarceva Advanced Consumer (Micromedex) - Includes Dosage Information


• Tarceva Consumer Overview


• Tarceva MedFacts Consumer Leaflet (Wolters Kluwer)


• Erlotinib Professional Patient Advice (Wolters Kluwer)

Compare Tarceva with other medications

• Non-Small Cell Lung Cancer
• Pancreatic Cancer
• Renal Cell Carcinoma

Where can I get more information?

• Your pharmacist can provide more information about erlotinib.

See also: Tarceva side effects (in more detail)

progestin contraceptive Oral, Implantation, Parenteral

Commonly used brand name(s)

In the U.S.

• Aygestin


• Camila


• Errin


• Jolivette


• Next Choice


• Nora-BE


• Nor-QD


• Ortho Micronor


• Ovrette


• Plan B


• Plan B One-Step


• Provera

Available Dosage Forms:

• Tablet

Uses For progestin contraceptive

Progestins are hormones.

The low-dose progestins for contraception are used to prevent pregnancy. Other names for progestin-only oral contraceptives are minipills and progestin-only pills (POPs). Progestins can prevent fertilization by preventing a woman's egg from fully developing.

Also, progestins cause changes at the opening of the uterus, such as thickening of the cervical mucus. This makes it hard for the partner's sperm to reach the egg. The fertilization of the woman's egg with her partner's sperm is less likely to occur while she is taking, receiving, or using a progestin, but it can occur. Even so, the progestins make it harder for the fertilized egg to become attached to the walls of the uterus, making it difficult to become pregnant.

No contraceptive method is 100 percent effective. Studies show that fewer than 1 of each 100 women become pregnant during the first year of use after correctly receiving the injection on time. Fewer than 10 of each 100 women who take progestins correctly by mouth for contraception become pregnant during the first year of use. Methods that do not work as well include condoms, diaphragms, or spermicides. Discuss with your doctor what your options are for birth control.

Progestin contraceptives are available only with your doctor's prescription.

Importance of Diet

Make certain your doctor knows if you are on any special diet, such as a low-sodium or low-sugar diet.

Before Using progestin contraceptive

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Progestins have been used by teenagers and have not been shown to cause different side effects or problems than they do in adults. You must take progestin-only oral contraceptives every day in order for them to work. Progestins do not protect against sexually transmitted diseases, a risk factor for teenagers. It is not known if Depo-Provera Contraceptive Injection causes problems with bone development and growth in teenagers and young women. It is important that your doctor check you regularly for growth problems, especially if you have been using progestin contraceptive for 2 years or longer.

Geriatric

progestin contraceptive has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Use of progestin-only contraceptives during pregnancy is not recommended. Doctors should be told if pregnancy is suspected. When accidently used during pregnancy, progestins used for contraception have not caused problems.

Breast Feeding

Although progestins pass into the breast milk, the low doses of progestins used for contraception have not been shown to cause problems in nursing babies. Progestins used for contraception are recommended for nursing mothers when contraception is desired.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Isotretinoin


• Theophylline


• Tizanidine


• Tranexamic Acid

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or


• Epilepsy, or history of or


• Heart or circulation problems or


• Kidney disease, severe or


• Migraine headaches—May cause fluid buildup and make these conditions worse.

• Bleeding problems, undiagnosed, such as blood in the urine or changes in vaginal bleeding—May make diagnosis of these problems more difficult.

• Breast disease (e.g., breast lumps or cysts), history of—May make this condition worse in certain types of diseases that do not react to progestins in a positive way.

• Central nervous system (CNS) disorders (e.g., depression), or history of or


• High blood cholesterol or


• Osteoporosis (brittle bones), or a family history of—May cause these conditions to occur or make these conditions worse.

• Diabetes mellitus—May cause a mild increase in blood sugar and a need to monitor blood sugar more often.

• Liver disease—The effects of some progestins may be increased. May make this condition worse.

Proper Use of progestin contraceptive

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins for contraception usually come with patient directions. Read them carefully before taking or using progestin contraceptive.

Progestins do not protect a woman from sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS). The use of latex (rubber) condoms or abstinence is recommended for protection from these diseases.

Take progestin contraceptive only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

When using levonorgestrel tablet dosage form for emergency contraception:

• The tablets may be taken at any time during the menstrual cycle.

When using medroxyprogesterone injection dosage form for contraception:

• Your injection is given by a health care professional every 3 months.


• To stop using medroxyprogesterone injection for contraception, simply do not have another injection.


• Full protection from pregnancy begins immediately if you receive the first injection within the first 5 days of your menstrual period or within 5 days after delivering a baby if you will not be breast-feeding. If you are going to breast-feed, you may have to wait for 6 weeks from your delivery date before receiving your first injection. If you follow this schedule, you do not need to use another form of birth control. Protection from that one injection ends at 3 months. You will need another injection every 3 months to have full protection from becoming pregnant. However, if the injection is given later than 5 days from the first day of your last menstrual period, you will need to use another method of birth control as directed by your doctor.

When using an oral progestin dosage form:

• Take a tablet every 24 hours each day of the year. Taking the medicine at the same time each day helps to reduce the possibility of side effects and makes it work as expected. Taking your tablet 3 hours late is the same as missing a dose and can cause the medicine to not work properly.


• Keep the tablets in the container in which you received them to help you to keep track of your dosage schedule.


• When switching from estrogen and progestin oral contraceptives, you should take the first dose of the progestin-only contraceptive the next day after the last active pill of the estrogen and progestin oral contraceptive has been taken. This means you will not take the last 7 days (placebo or nonactive pills) of a 28-day cycle of the estrogen and progestin oral contraceptive pack. You will begin a new pack of progestin-only birth control pills on the 22nd day.


• Also, when switching, full protection from pregnancy begins after 48 hours if the first dose of the progestin-only contraceptive is taken on the first day of the menstrual period. If the birth control is begun on other days, full protection may begin 3 weeks after you begin taking the medicine for the first time. You should use a second method of birth control for at least the first 3 weeks to ensure full protection. You are not fully protected if you miss pills. The chances of your getting pregnant are greater with each pill that is missed.

Follow your doctor's orders to schedule the proper time to receive an injection of progestins for contraception.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For levonorgestrel


• For oral dosage form (tablets):
  
  • For emergency contraception for preventing pregnancy:
    
    • Adults and teenagers—The first dose of 0.75 milligram should be taken as soon as possible within 72 hours of intercourse. The second dose must be taken 12 hours later.
    
    
  
  

• For medroxyprogesterone


• For muscular injection dosage form
  
  • For preventing pregnancy:
    
    • Adults and teenagers—150 milligrams injected into a muscle in the upper arm or in the buttocks every three months (13 weeks).
    
    
  
  


• For subcutaneous injection dosage form
  
  • For preventing pregnancy:
    
    • Adults and teenagers—104 milligrams injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks).
    
    
  
  

• For norethindrone


• For oral dosage form (tablets):
  
  • For preventing pregnancy:
    
    • Adults and teenagers—0.35 milligrams every 24 hours, beginning on the first day of your menstrual cycle whether menstrual bleeding begins or not. The first day of your menstrual cycle can be figured out by counting 28 days from the first day of your last menstrual cycle.
    
    
  
  

• For norgestrel


• For oral dosage form (tablets):
  
  • For preventing pregnancy:
    
    • Adults and teenagers—75 micrograms every 24 hours, beginning on the first day of your menstrual cycle whether menstrual bleeding occurs or not. The first day of your menstrual cycle can be figured out by counting 28 days from the first day of your last menstrual cycle.
    
    
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

For oral dosage form (tablets):

• When you miss 1 day's dose of oral tablets or are 3 hours or more late in taking your dose, many doctors recommend that you take the missed dose immediately, continue your normal schedule, and use another method of contraception for 2 days. This is different from what is done after a person misses a dose of birth control tablets that contain more than one hormone.

For injection dosage form:

• If you miss having your next injection and it has been longer than 13 weeks since your last injection, your doctor may want you to stop receiving the medicine. Use another method of birth control until your period begins or until your doctor determines that you are not pregnant.


• If your doctor has other directions, follow that advice. Any time you miss a menstrual period within 45 days after a missed or delayed dose you will need to be tested for a possible pregnancy.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using progestin contraceptive

It is very important that your doctor check your progress at regular visits. This will allow your dosage to be adjusted to your changing needs, and will allow any unwanted effects to be detected. These visits are usually every 12 months when you are taking progestins by mouth for birth control.

• If you are receiving the medroxyprogesterone injection for contraception, a physical exam is needed only every 12 months, but you need an injection every 3 months. Your doctor will also want to check you for any bone development or growth problems, especially if you are a teenager or young adult.

Progestins may cause dizziness in some people. Make sure you know how you react to progestin contraceptive before you drive, use machines, or do anything else that could be dangerous if you are not alert.

It is possible that certain doses of progestins may cause a temporary thinning of the bones by changing your hormone balance. It is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as steroids (cortisone-like medicines) or anticonvulsants (seizure medicines), can also cause thinning of the bones. It is especially important that you tell your doctor about any of these risk factors if you are taking Depo-Provera® Contraceptive Injection or Depo-SubQ Provera® 104. These contraceptives may cause a loss of bone mineral density. Your doctor may replace these contraceptives with a different one.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is not unusual and does not mean you should stop the medicine. This is sometimes called spotting when the bleeding is slight, or breakthrough bleeding when it is heavier. If this occurs, continue on your regular dosing schedule. Check with your doctor:

• If vaginal bleeding continues for an unusually long time.


• If your menstrual period has not started within 45 days of your last period.

Missed menstrual periods may occur. If you suspect a pregnancy, you should call your doctor immediately.

If you are scheduled for any laboratory tests, tell your doctor that you are taking a progestin. Progestins can change certain test results.

The following medicines might reduce the effectiveness of progestins for contraception:

• Aminoglutethimide (e.g., Cytadren®)


• Carbamazepine (e.g., Tegretol®)


• Phenobarbital


• Phenytoin (e.g., Dilantin®)


• Rifabutin (e.g., Mycobutin®)


• Rifampin (e.g., Rifadin®)

Sometimes your doctor may use these medicines with progestins for contraception, but the doctor will give you special directions to follow to make sure your progestin is working properly. In order to prevent pregnancy, use a second method of birth control together with the progestin when you also use a medicine that could reduce the effectiveness of the progestin. If you are using medroxyprogesterone injection for contraception, continue using a back-up method of birth control until you have your next injection, even if the medicine that affects contraceptives is discontinued. If you are using the oral tablets, continue using a back-up method of birth control for a full cycle (or 4 weeks), even if the medicine that affects contraceptives is discontinued.

If you vomit your oral progestin-only contraceptive for any reason within a few hours after taking it, do not take another dose. Return to your regular dosing schedule and use an additional back-up method of birth control for 48 hours.

If you are receiving levonorgestrel tablets for emergency contraception and vomiting occurs within 1 hour after taking either dose of the medicine, contact your physician to discuss whether the dose should be repeated.

progestin contraceptive Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Changes in uterine bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods


• heavier uterine bleeding between regular monthly periods


• lighter uterine bleeding between menstrual periods


• or stopping of menstrual periods

Less common

• Mental depression


• skin rash


• unexpected or increased flow of breast milk

Incidence not known - for patients taking Depo-Provera Contraceptive Injection

• Cough


• decrease in height


• difficulty swallowing


• fast heartbeat


• hives, itching, puffiness, or swelling of the eyelids or around the eyes, face, lips or tongue


• pain in back, ribs, arms, or legs


• pain or swelling in arms or legs without any injury


• shortness of breath


• skin rash


• tightness in chest


• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal pain or cramping


• diarrhea


• dizziness


• fatigue


• mild headache


• mood changes


• nausea


• nervousness


• pain or irritation at the injection site


• swelling of face, ankles, or feet


• unusual tiredness or weakness


• vomiting


• weight gain

Less common

• Acne


• breast pain or tenderness


• brown spots on exposed skin, possibly long-lasting


• hot flashes


• loss or gain of body, facial, or scalp hair


• loss of sexual desire


• trouble in sleeping

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.

After you stop using progestin contraceptive, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time, check with your doctor if you notice any of the following side effects:

• Delayed return to fertility


• stopping of menstrual periods


• unusual menstrual bleeding (continuing)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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