Find Medicines

Ketotifen is indicated in the following conditions-

• For the prophylactic treatment of bronchial asthma.
• Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.
• For alleviating the complications of itching, pain and tenderness associated with neurofibroma.
• Symptomatic treatment of allergy such as hayfever, urticaria.

Cromoglycate & related drugs

Ketotifen has anti-allergic properties and has been used similarly, to sodium chromoglycate in the prophylactic treatment of asthma. It also has the properties of an antihistamine. Ketotifen possesses marked anti-anaphylactic properties and is effective in preventing an asthmatic attacks. Ketotifen exerts as sustained inhibitory effect on histamine reactions, which can be clearly dissociated from its anti-anaphylactic properties. Experimental investigations in asthmatic subjects have shown that Ketotifen is as effective orally as a selective mast cell stabilizer administered by inhalation. Antihistamines were ineffective in those tests. The effectiveness of Ketotifen has been studied in long-term clinical trials. Asthma attacks were reduced in number, severity and duration and in some cases, the patients were completely freed from attacks. Progressive reduction of corticosteroids and/or bronchodilators was also possible. The prophylactic activity of Ketotifen may take several weeks to become fully established. Ketotifen will not abort established attacks of asthma.

Adults: 1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily in severe cases.

Children above 3 years: 1 mg twice daily with food. Patients known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician.

Use in elderly: Same as adult dose or as advised by the physician.

Drowsiness and in isolated cases, dry mouth and slight dizziness may occur at the beginning of treatment but usually disappear spontaneously after a few days.

A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly with oral antidiabetic agent and it has been suggested that this combination should therefore be avoided. Although there is no evidence of any teratogenic effect, recommendations for Ketotifen in pregnancy or when breast feeding can not be given.

It is important to continue the previous treatment for a minimum of two weeks after starting Ketotifen to avoid the possibility of exacerbation of asthma. This applies specially to systemic corticosteroids and ACTH because of the possible existence of adrenocortical insufficiency in steroid dependent patient. If inter current infection occurs, Ketotifen treatment must be supplemented by specific antimicrobial therapy. During the first day of treatment with Ketotifen, reactions may be impaired and patients should be warned not to take charge of vehicle or machinery until the effect of Ketotifen treatment on the individual is known. Patients should be advised to avoid alcoholic drinks. Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohol.

Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohols. A reversible fall in the platelet count has been observed in a few patients receiving Tifen concomitantly with oral antidiabetic agents and it has been suggested that this combination should therefore be avoided.

Although there is no evidence of any teratogenic effect, Ketotifen in pregnancy and lactation is not recommended.

The reported features of overdosage include confusion, drowsiness, headache, bradycardia, respiratory depression etc. should be watched for. Elimination of the drug with gastric lavage or emessis is recommended. Otherwise, general supportive treatment is all that is required shall be instituted.

Store in a cool and dry place, protect from light. Keep out of the reach of children.

Ketotifen is indicated in the following conditions-

• For the prophylactic treatment of bronchial asthma.
• Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.
• For alleviating the complications of itching, pain and tenderness associated with neurofibroma.
• Symptomatic treatment of allergy such as hayfever, urticaria.

Cromoglycate & related drugs

Ketotifen has anti-allergic properties and has been used similarly, to sodium chromoglycate in the prophylactic treatment of asthma. It also has the properties of an antihistamine. Ketotifen possesses marked anti-anaphylactic properties and is effective in preventing an asthmatic attacks. Ketotifen exerts as sustained inhibitory effect on histamine reactions, which can be clearly dissociated from its anti-anaphylactic properties. Experimental investigations in asthmatic subjects have shown that Ketotifen is as effective orally as a selective mast cell stabilizer administered by inhalation. Antihistamines were ineffective in those tests. The effectiveness of Ketotifen has been studied in long-term clinical trials. Asthma attacks were reduced in number, severity and duration and in some cases, the patients were completely freed from attacks. Progressive reduction of corticosteroids and/or bronchodilators was also possible. The prophylactic activity of Ketotifen may take several weeks to become fully established. Ketotifen will not abort established attacks of asthma.

Adults: 1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily in severe cases.

Children above 3 years: 1 mg twice daily with food. Patients known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician.

Use in elderly: Same as adult dose or as advised by the physician.

Drowsiness and in isolated cases, dry mouth and slight dizziness may occur at the beginning of treatment but usually disappear spontaneously after a few days.

A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly with oral antidiabetic agent and it has been suggested that this combination should therefore be avoided. Although there is no evidence of any teratogenic effect, recommendations for Ketotifen in pregnancy or when breast feeding can not be given.

It is important to continue the previous treatment for a minimum of two weeks after starting Ketotifen to avoid the possibility of exacerbation of asthma. This applies specially to systemic corticosteroids and ACTH because of the possible existence of adrenocortical insufficiency in steroid dependent patient. If inter current infection occurs, Ketotifen treatment must be supplemented by specific antimicrobial therapy. During the first day of treatment with Ketotifen, reactions may be impaired and patients should be warned not to take charge of vehicle or machinery until the effect of Ketotifen treatment on the individual is known. Patients should be advised to avoid alcoholic drinks. Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohol.

Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohols. A reversible fall in the platelet count has been observed in a few patients receiving Tifen concomitantly with oral antidiabetic agents and it has been suggested that this combination should therefore be avoided.

Although there is no evidence of any teratogenic effect, Ketotifen in pregnancy and lactation is not recommended.

The reported features of overdosage include confusion, drowsiness, headache, bradycardia, respiratory depression etc. should be watched for. Elimination of the drug with gastric lavage or emessis is recommended. Otherwise, general supportive treatment is all that is required shall be instituted.

Store in a cool and dry place, protect from light. Keep out of the reach of children.

Cough suppressant

Butamirate Citrate acts directly on the brain's cough center to suppress cough. Butamirate Citrate is safe and non-sedating which is neither chemically nor pharmacologically related to opium alkaloids. Butamirate Citrate is rapidly and completely absorbed after oral administration. Maximum concentration is reached within 9 hours with the sustained-release tablet. This is extremely protein-bound and plasma elimination half-life is about 13 hours. The active metabolites of Butamirate Citrate have also antitussive action.

Use in adult:

• Butamirate Citrate 50 mg tablet: 2-3 tablets daily.
• Butamirate Citrate syrup: 15 ml 4 times daily.

Use in children & adolescents:
Butamirate Citrate 50 mg tablet:

• Adolescent over 12 years old: 1-2 tablets daily.

Butamirate Citrate syrup:

• Children (3-6 yrs): 5 ml 3 times daily.
• Children (6-12 yrs): 10 ml 3 times daily.
• Adolescent: 15 ml 3 times daily.

Butamirate Citrate pediatric drops:

• Children ( 2 months- 1 yrs): 0.50 ml 4 times daily.
• Children (1-3 yrs): 0.75 ml 4 times daily.

Tolerance of Butamirate Citrate is good.Adverse reactions such as rash,nausea,diarrhoea and vertigo have been observed in a few rare cases,resolving after dose reduction or treatment withdrawal.

Hypersensitivity to the active ingredient.

Butamirate Citrate suppresses the cough reflex and therefore the concomitant use with expectorants should be avoided, since it may lead to mucus retention in the airways, which increases the risk of bronchospasm and respiratory infections. If the cough persists for more than 7 days (more than 3 days in children younger than12 years of age) doctor must be consulted.

Concomitant use with expectorants should be avoided.

Butamirate Citrate should not be used during the first trimester of pregnancy. During the remainder of pregnancy, it can be used if indicated by a physician but with caution. As a general rule, for safety reasons, in the absence of data on elimination of the active substance in breast milk, the benefits of Butamirate Citrate administration during breast feeding should be carefully weighed against the risks.

Accidental overdose with Butamirate Citrate can cause the following symptoms: drowsiness, nausea, vomiting, diarrhoea, loss of balance and hypotension. Standard emergency procedures should be followed: activated charcoal, saline laxatives and standard cardio-respiratory resuscitation.

Keep away from light and moisture, store below 30°C. Keep all the medicines out of the reach of children.

Cough suppressant

Butamirate Citrate acts directly on the brain's cough center to suppress cough. Butamirate Citrate is safe and non-sedating which is neither chemically nor pharmacologically related to opium alkaloids. Butamirate Citrate is rapidly and completely absorbed after oral administration. Maximum concentration is reached within 9 hours with the sustained-release tablet. This is extremely protein-bound and plasma elimination half-life is about 13 hours. The active metabolites of Butamirate Citrate have also antitussive action.

Use in adult:

• Butamirate Citrate 50 mg tablet: 2-3 tablets daily.
• Butamirate Citrate syrup: 15 ml 4 times daily.

Use in children & adolescents:
Butamirate Citrate 50 mg tablet:

• Adolescent over 12 years old: 1-2 tablets daily.

Butamirate Citrate syrup:

• Children (3-6 yrs): 5 ml 3 times daily.
• Children (6-12 yrs): 10 ml 3 times daily.
• Adolescent: 15 ml 3 times daily.

Butamirate Citrate pediatric drops:

• Children ( 2 months- 1 yrs): 0.50 ml 4 times daily.
• Children (1-3 yrs): 0.75 ml 4 times daily.

Tolerance of Butamirate Citrate is good.Adverse reactions such as rash,nausea,diarrhoea and vertigo have been observed in a few rare cases,resolving after dose reduction or treatment withdrawal.

Hypersensitivity to the active ingredient.

Butamirate Citrate suppresses the cough reflex and therefore the concomitant use with expectorants should be avoided, since it may lead to mucus retention in the airways, which increases the risk of bronchospasm and respiratory infections. If the cough persists for more than 7 days (more than 3 days in children younger than12 years of age) doctor must be consulted.

Concomitant use with expectorants should be avoided.

Butamirate Citrate should not be used during the first trimester of pregnancy. During the remainder of pregnancy, it can be used if indicated by a physician but with caution. As a general rule, for safety reasons, in the absence of data on elimination of the active substance in breast milk, the benefits of Butamirate Citrate administration during breast feeding should be carefully weighed against the risks.

Accidental overdose with Butamirate Citrate can cause the following symptoms: drowsiness, nausea, vomiting, diarrhoea, loss of balance and hypotension. Standard emergency procedures should be followed: activated charcoal, saline laxatives and standard cardio-respiratory resuscitation.

Keep away from light and moisture, store below 30°C. Keep all the medicines out of the reach of children.

Cough suppressant

Butamirate Citrate acts directly on the brain's cough center to suppress cough. Butamirate Citrate is safe and non-sedating which is neither chemically nor pharmacologically related to opium alkaloids. Butamirate Citrate is rapidly and completely absorbed after oral administration. Maximum concentration is reached within 9 hours with the sustained-release tablet. This is extremely protein-bound and plasma elimination half-life is about 13 hours. The active metabolites of Butamirate Citrate have also antitussive action.

Use in adult:

• Butamirate Citrate 50 mg tablet: 2-3 tablets daily.
• Butamirate Citrate syrup: 15 ml 4 times daily.

Use in children & adolescents:
Butamirate Citrate 50 mg tablet:

• Adolescent over 12 years old: 1-2 tablets daily.

Butamirate Citrate syrup:

• Children (3-6 yrs): 5 ml 3 times daily.
• Children (6-12 yrs): 10 ml 3 times daily.
• Adolescent: 15 ml 3 times daily.

Butamirate Citrate pediatric drops:

• Children ( 2 months- 1 yrs): 0.50 ml 4 times daily.
• Children (1-3 yrs): 0.75 ml 4 times daily.

Tolerance of Butamirate Citrate is good.Adverse reactions such as rash,nausea,diarrhoea and vertigo have been observed in a few rare cases,resolving after dose reduction or treatment withdrawal.

Hypersensitivity to the active ingredient.

Butamirate Citrate suppresses the cough reflex and therefore the concomitant use with expectorants should be avoided, since it may lead to mucus retention in the airways, which increases the risk of bronchospasm and respiratory infections. If the cough persists for more than 7 days (more than 3 days in children younger than12 years of age) doctor must be consulted.

Concomitant use with expectorants should be avoided.

Butamirate Citrate should not be used during the first trimester of pregnancy. During the remainder of pregnancy, it can be used if indicated by a physician but with caution. As a general rule, for safety reasons, in the absence of data on elimination of the active substance in breast milk, the benefits of Butamirate Citrate administration during breast feeding should be carefully weighed against the risks.

Accidental overdose with Butamirate Citrate can cause the following symptoms: drowsiness, nausea, vomiting, diarrhoea, loss of balance and hypotension. Standard emergency procedures should be followed: activated charcoal, saline laxatives and standard cardio-respiratory resuscitation.

Keep away from light and moisture, store below 30°C. Keep all the medicines out of the reach of children.

This herbal cough syrup liquefies phlegm. It soothes irritation of the throat. Helps to relieve hoarseness. It is a remedy for all types of cough such as dry irritable cough, allergic & smokers cough.

Herbal and Nutraceuticals

Children under 12 years: 1-2 teaspoonful (5-10 ml) 2-3 times a day. '
Adult: 3 teaspoonful (15 ml) 2-3 times a day.
Some warm water may be added for better results.

This syrup is proven as safe. It is well tolerated. In high dose diarrhea, vomiting may occur.

No report is available on contraindication. It may be happen in patients who are hypersensitive to any of its ingredients.

No report is available.

The safety of this syrup in pregnancy has not been studied. Therefore, it should be used with caution during pregnancy.

Keep out of reach of children. Keep away from direct sunlight. Store in a cool and dry place.

Temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• cough due to minor throat or bronchial irritation
• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• nasal congestion
• reduces swelling of nasal passages

Combined cough suppressants

This preparation is a mixture of antitussive, decongestant and antihistamine agent. Dextromethorphan is a safe, effective, non-narcotic antitussive agent which has a central action on the cough centre in the medulla. Although structurally related to Morphine, it has no analgesic and habit forming properties and in general it has little sedative activity. Phenylephrine is a decongestant that shrinks blood vessels in the nasal passage. It is used to treat nasal and sinus congestion of the tubes that drain fluid from inner ear. Triprolidine provides symptomatic relief in conditions believed to depend wholly or partly upon the triggered release of histamine. It is a potent competitive histamine H1-receptor antagonist of the pyrrolidine class with mild central nervous system depressant properties which may cause drowsiness.

Adults & Children 12 years of age and older: 1 teaspoonful (5 ml) every 4 hours, or as directed by a doctor.

Children 6 to under 12 years of age: ½ teaspoonful (2.5 ml) every 4 hours, or as directed by a doctor.

Children below 2 years old: Not to be used in children below 2 years old. To be used with caution, and as advised by the physician for children age 2 to 6 years.

Take with or without food. Take with food if it causes an upset stomach. Measure liquid doses carefully. Use the measuring device that comes with this medicine.

It may cause drowsiness, dottiness and constipation. Other side effects that may occur include GIT discomfort. No apparent evidence of physical dependence of the morphine type. Other less common side effects may include transient hypertension, dry mouth, restlessness, palpitations, allergic reactions such as rashes, tightness of chest, thickening of bronchial secretions, toxic psychosis and blood dyscrasia.

It should be avoided in patients with liver disease or asthmatic patients and is contraindicated in patients taking monoamine oxidase inhibitors or within 2 weeks from stopping such treatment, known hypersensitivity to phenylephrine hydrochloride, dextromethorphan hydrobromide and during acute attacks of asthma. It is contraindicated in patients with severe hypertension or severe coronary artery disease.

This preparation may cause drowsiness. If affected, do not drive motor vehicle or operate machinery. Avoid alcoholic drink while on this medication. Use with caution in patients with epilepsy, prostatic hypertrophy, glaucoma, hepatic disease, hypertension, heart disease, diabetes, hyperthyroidism, patients with stenosing peptic ulcer, pyloro-duodenal obstruction or bladder neck obstruction, unless under the medical advice and supervision. If symptoms do not improve within one week or accompanied with high fever, consult a physician before continuing use.

Taking certain MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking isocarboxazid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, or tranylcypromine during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Caution should be excercised while taking this drug with antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray), antispasmodics (e.g. atropine, belladonna alkaloids), beta blockers (e.g. metoprolol, atenolol), drugs for Parkinson’s disease (e.g. anticholinergics such as benztropine, trihexyphenidyl), guanethidine, certain inhaled anesthetics (e.g. halothane), methyldopa, reserpine, scopolamine, tricyclic antidepressants (e.g. amitriptyline, desipramine), anti seizure drugs (e.g. carbamazepine), medicine for sleep or anxiety (e.g. alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g. codeine), psychiatric medicines (e.g. chlorpromazine, risperidone, amitriptyline, trazodone).

As with any other drugs, use in pregnancy and lactation is best avoided.

In cases of over dosage, hospital admission is strongly advised. Over dosage may produce respiratory depression, paranoid psychosis, delusions, hallucinations, and convulsion. Treatment should include emptying the stomach by aspiration or gastric lavage. Nervous stimulation and convulsions should be treated with a sedative such as diazepam intramuscularly. If marked excitation is present, a sedative such as diazepam or a short-acting barbiturate may be given.

Severe over dosage of phenylephrine hydrochloride may produce hypertension and associated reflex bradycardia. Treatment measures include early gastric lavage and symptomatic and supportive measures. The hypertensive effects may be treated with an alpha-receptor blocking agent (such as phentolamine mesilate 6-10 mg) given intravenously, and the bradycardia treated with atropine, preferable only after the pressure has been controlled.

Keep out of the reach of children. Keep in a cool & dry place. Protect from light.

This is indicated for the symptomatic relief of upper respiratory tract disorders accompanied by productive cough which benefits from the administration of a nasal decongestant, a histamine H1 receptor antagonist and an expectorant combination.

Combined cough expectorants

Pseudoephedrine is a decongestant as well as a bronchodilator for the upper respiratory tract, which gives symptomatic relief of nasal congestion. Pseudoephedrine is both an α-and β-adrenergic receptor agonist. It causes vasoconstriction via direct stimulation of α-adrenergic receptors of the respiratory mucosa. It also directly stimulates β-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility.

Like ephedrine, pseudoephedrine releasing norepinephrine from its storage sites, an indirect effect. This is its main and direct mechanism of action. The displaced noradrenaline is released into the neuronal synapse where it is free to activate the postsynaptic adrenergic receptors.

Guaifenesin reduces the viscosity of tenacious sputum and is used as an expectorant. It increases the hydration of respiratory tract, thereby increasing the volume and reducing the viscosity of bronchial secretions.

Triprolidine is an antihistamine; it is used for the symptomatic relief of hypersensitivity reactions including rhinitis, conjunctivitis and urticaria.

Adult and Children over 12 years: 10 ml (2 teaspoonful) three times a day.
Children 6-12 years: 5 ml (1 teaspoonful) three times a day.
Children 2-5 years: 2.5 ml (1/2 teaspoonful) three times a day.

A physician’s advice is preferred before administering this preparation to children aged less than 2 years.

CNS depression or excitation, drowsiness (reported most frequently), sleep disturbances, hallucinations (rarely reported), skin rashes with or without irritation, tachycardia, dryness of mouth, nose and throat have occasionally been reported.

This is contraindicated in the cases of known hypersensitivity to any of its constituents, cardiovascular disease including hypertension, lower respiratory symptoms including asthma, monoamine oxidase inhibitor (MAOI) therapy.

As with any other antihistamine therapy, Pseudoephedrine, guaiphenasine & triprolidine may cause drowsiness. If affected, patients should be advised not to drive or operate machinery. Concomitant administration of alcohol or other centrally acting sedatives should be avoided. Although Pseudoephedrine has no pressor effects in normotensive patients but Pseudoephedrine, guaiphenasine & triprolidine should be used with caution to patients suffering from mild to moderate hypertension. Moreover, caution should also be exercised in the following disease conditions - hypertension and heart disease, diabetes, hyperthyroidism, elevated intra-ocular pressure, prostatic enlargement, severe renal and hepatic impairment. This preparation should not be used for persistent or chronic cough, which occurs with smoking, asthma or emphysema or where excessive secretions accompany cough, unless directed by a physician.

Concomitant use of Pseudoephedrine, guaiphenasine & triprolidine with sympathomimetic agents such as decongestants, tricyclic antidepressants, appetite suppressants and amphetamine-like psychostimulants or with monoamine oxidase inhibitors which interfere with the catabolism of sympathomimetic amines may occasionally cause a rise in blood pressure. Because of its pseudoephedrine content, Pseudoephedrine, guaiphenasine & triprolidine partially reverse the hypotensive action of drugs which interfere with sympathetic activity including guanethidine, methyldopa, alpha-adrenergic blocking agents.

Although pseudoephedrine, triprolidine and guaiphenesin have been in widespread use of many years without apparent ill consequence, there are no specific data on their use during pregnancy. Caution should therefore be exercised by balancing the potential benefits of treatment of the mother against any possible hazards to the developing fetus.

The effects of acute toxicity from Pseudoephedrine, guaiphenasine & triprolidine may include drowsiness, irritability, restlessness, lethargy, dizziness, gastrointestinal discomfort, respiratory depression, convulsion, tremor, tachycardia and hypertension. Incase of overdose, necessary measures should be taken to maintain and support respiration and control convulsion. Gastric lavage may be undertaken if indicated. Catheterization of bladder may be necessary.

Store below 25° C. Protect from light. Do not refrigerate.

This preparation temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• Non-productive cough due to minor throat or bronchial irritation
• Runny Nose
• Sneezing
• Itching of the nose or throat
• Itchy & watery eyes
• Nasal congestion

Combined cough suppressants

This preparation is a mixture of antitussive, decongestant and antihistamine agent. Dextromethorphan is a safe, effective, non-narcotic antitussive agent which has a central action on the cough centre in the medulla. Although structurally related to Morphine, it has no analgesic and habit forming properties and in general it has little sedative activity. Phenylephrine is a decongestant that shrinks blood vessels in the nasal passage. Phenylephrine is used for the temporary relief of stuffy nose, sinus, and ear symptoms caused by the common cold, flu, allergies, sinusitis & bronchitis. This medication works by decreasing swelling in the nose and ears, thereby lessening discomfort and making it easier to breathe. Triprolidine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, watery eyes, itchy eyes/nose/throat/skin, cough, runny nose, and sneezing. It is a potent competitive histamine H1-receptor antagonist of the pyrrolidine class with mild central nervous system depressant properties which may cause drowsiness. By antagonizing another natural substance acetylcholine, it helps dry up some body fluids to relieve symptoms such as watery eyes and runny nose.

Adults & Children over 12 years: 1 teaspoonful (5 ml) 4 times a day every 4 hours interval.

6-12 years: 1/2 teaspoonful 4 times a day every 4 hours interval.

Use in children and adolescents: A physician's advice should be obtained before administering this combination to children less than 6 years.

It may cause drowsiness and constipation. Other side effects that may occur include GIT discomfort. No apparent evidence of physical dependence of the morphine type.

It should be avoided in patients with liver disease or asthmatic patients and is contraindicated in patients taking monoamine oxidase inhibitors or within 2 weeks from stopping such treatment

This preparation may cause drowsiness. If affected, do not drive motor vehicle or operate machinery. Avoid alcoholic drink while on this medication. Use with caution in patients with epilepsy, prostatic hypertrophy, glaucoma, hepatic disease, hypertension, heart disease, diabetes, hyperthyroidism. If symptoms do not improve within one week or accompanied with high fever, consult a physician before continuing use.

Taking certain MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking isocarboxazid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, or tranylcypromine during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication.

There are no specific data on use of this combination during pregnancy & lactation.

In cases of over dosage, hospital admission is strongly advised. Over dosage may produce respiratory depression, paranoid psychosis, delusions, hallucinations and convulsion.

Store in a cool and dry place (below 30°C temperature), away from light. Keep out of the reach of children.

Colchicine are indicated for treatment of acute gout flares. And also indicated in Familial Mediterranean fever (FMF) in adults and children 4 years or older.

Drugs used in Gout

An acute attack of gout apparently occurs as a result of an inflammatory reaction to crystals of monosodium urate that are deposited in the joint tissue from hyperuric body fluids; the reaction is aggravated as more urate crystals accumulate. Leukocytes migrate to the sites where urate crystals have been deposited and try to engulf the crystals by phagocytosis. As a result lactic acid and proinflammatory enzymes are released which cause inflammation with severe pain, redness, and swelling of the affected joint. Lactic acid favors a local decrease in pH that enhances uric acid deposition. Colchicine inhibits the phagocytosis of uric acid by leukocytes & also diminishes the lactic acid production directly. Thus interrupts the cycle of urate crystal deposition and inflammatory response that sustains the acute attack of gout.

Colchicine is absorbed when given orally, reaching a mean Cmax of 2.5 ng/mL (range 1.1 to 4.4 ng/mL) in 1 to 2 hours after a single dose administered under fasting conditions. The mean apparent volume of distribution is approximately 5 to 8 L/kg. Colchicine binding to serum protein is low (39 ± 5%), primarily to albumin regardless of concentration. CYP3A4 is involved in the metabolism of Colchicine to 2-O-demethylcolchicine and 3-O-demethylcolchicine. Plasma levels of these metabolites are minimal (less than 5% of parent drug). Following multiple oral doses (0.6 mg twice daily), the mean elimination half-life is 26.6 to 31.2 hours.

Acute gouty arthritis:

• First dose- 1 to 1.2 mg (two 0.5 mg or two 0.6 mg tablets) at a time every 2 hours until pain and inflammation aborted.
• The total amount of colchicine needed to control pain and inflammation during an attack usually ranges from 4 to 8 mg.
• Articular pain and swelling typically reduced within 12 hours and are usually gone in 24 to 48 hours, An interval of three days between colchicine courses is advised in order to minimize the possibility of cumulative toxicity.

For prophylaxis during intercritical periods:

• To reduce the frequency of their severity, colchicine may be administered continuously.
• In patients who have less than one attack per year, the usual dose is 0.5 or 0.6 mg per day, three or four days a week.
• For cases involving more than one attack per year, the usual dose is 0.5 or 0.6 mg daily.
• Severe cases may require two or three 0.5 mg or 0.6 mg tablets daily.

For prophylaxis against attacks of gout in patients undergoing surgery:

• In patients with gout, an attack may be precipitated by even a minor surgical procedure. One 0.5 mg tablet or one 0.6 mg tablet three times daily should be administered for three days before and three days after surgery.

Blood dyscrasias: Myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, and aplastic anemia have been reported. Diarrhea and pharyngolaryngeal pain may occur.

Patients with renal or hepatic impairment should not be given Colchicine in conjunction with Permeability glycoprotein (P-gp) or strong CYP3A4 inhibitors (e.g., clarithromycin or cyclosporine).

Co-administration of P-gp and/or CYP3A4 inhibitors (e.g., clarithromycin or cyclosporine) have been demonstrated to alter the concentration of Colchicine

Pregnancy Category C. There are no adequate and well-controlled studies with Colchicine in pregnant women. Colchicine is excreted into human milk. Caution should be exercised when administered to a nursing woman.

Pediatric Use: Gout is rare in pediatric patients. Safety and effectiveness of Colchicine in pediatric patients have not been established.

The exact dose of colchicine that produces significant toxicity is unknown. Fatalities have occurred after ingestion of a dose as low as 7 mg over a 4-day period, while other patients have survived after ingesting more than 60 mg. A review of 150 patients who overdosed on colchicine found that those who ingested less than 0.5 mg/kg survived and tended to have milder toxicities, such as gastrointestinal symptoms, whereas those who took 0.5 to 0.8 mg/kg had more severe reactions, such as myelosuppression.

Store below 30°C temperature. Protect from light and moisture. Keep the medicine out of reach of children.

Colchicine are indicated for treatment of acute gout flares. And also indicated in Familial Mediterranean fever (FMF) in adults and children 4 years or older.

Drugs used in Gout

An acute attack of gout apparently occurs as a result of an inflammatory reaction to crystals of monosodium urate that are deposited in the joint tissue from hyperuric body fluids; the reaction is aggravated as more urate crystals accumulate. Leukocytes migrate to the sites where urate crystals have been deposited and try to engulf the crystals by phagocytosis. As a result lactic acid and proinflammatory enzymes are released which cause inflammation with severe pain, redness, and swelling of the affected joint. Lactic acid favors a local decrease in pH that enhances uric acid deposition. Colchicine inhibits the phagocytosis of uric acid by leukocytes & also diminishes the lactic acid production directly. Thus interrupts the cycle of urate crystal deposition and inflammatory response that sustains the acute attack of gout.

Colchicine is absorbed when given orally, reaching a mean Cmax of 2.5 ng/mL (range 1.1 to 4.4 ng/mL) in 1 to 2 hours after a single dose administered under fasting conditions. The mean apparent volume of distribution is approximately 5 to 8 L/kg. Colchicine binding to serum protein is low (39 ± 5%), primarily to albumin regardless of concentration. CYP3A4 is involved in the metabolism of Colchicine to 2-O-demethylcolchicine and 3-O-demethylcolchicine. Plasma levels of these metabolites are minimal (less than 5% of parent drug). Following multiple oral doses (0.6 mg twice daily), the mean elimination half-life is 26.6 to 31.2 hours.

Acute gouty arthritis:

• First dose- 1 to 1.2 mg (two 0.5 mg or two 0.6 mg tablets) at a time every 2 hours until pain and inflammation aborted.
• The total amount of colchicine needed to control pain and inflammation during an attack usually ranges from 4 to 8 mg.
• Articular pain and swelling typically reduced within 12 hours and are usually gone in 24 to 48 hours, An interval of three days between colchicine courses is advised in order to minimize the possibility of cumulative toxicity.

For prophylaxis during intercritical periods:

• To reduce the frequency of their severity, colchicine may be administered continuously.
• In patients who have less than one attack per year, the usual dose is 0.5 or 0.6 mg per day, three or four days a week.
• For cases involving more than one attack per year, the usual dose is 0.5 or 0.6 mg daily.
• Severe cases may require two or three 0.5 mg or 0.6 mg tablets daily.

For prophylaxis against attacks of gout in patients undergoing surgery:

• In patients with gout, an attack may be precipitated by even a minor surgical procedure. One 0.5 mg tablet or one 0.6 mg tablet three times daily should be administered for three days before and three days after surgery.

Blood dyscrasias: Myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, and aplastic anemia have been reported. Diarrhea and pharyngolaryngeal pain may occur.

Patients with renal or hepatic impairment should not be given Colchicine in conjunction with Permeability glycoprotein (P-gp) or strong CYP3A4 inhibitors (e.g., clarithromycin or cyclosporine).

Co-administration of P-gp and/or CYP3A4 inhibitors (e.g., clarithromycin or cyclosporine) have been demonstrated to alter the concentration of Colchicine

Pregnancy Category C. There are no adequate and well-controlled studies with Colchicine in pregnant women. Colchicine is excreted into human milk. Caution should be exercised when administered to a nursing woman.

Pediatric Use: Gout is rare in pediatric patients. Safety and effectiveness of Colchicine in pediatric patients have not been established.

The exact dose of colchicine that produces significant toxicity is unknown. Fatalities have occurred after ingestion of a dose as low as 7 mg over a 4-day period, while other patients have survived after ingesting more than 60 mg. A review of 150 patients who overdosed on colchicine found that those who ingested less than 0.5 mg/kg survived and tended to have milder toxicities, such as gastrointestinal symptoms, whereas those who took 0.5 to 0.8 mg/kg had more severe reactions, such as myelosuppression.

Store below 30°C temperature. Protect from light and moisture. Keep the medicine out of reach of children.

Cholera Saline contains different electrolytes which are usually depleted in various conditions e.g. diarrhoea, vomiting, profuse sweating etc. So, this saline is indicated in cholera, also in diarrhoea, vomiting, fluid loss, to replenish and restore the normal electrolyte balance of the body.

Intravenous fluid preparations

The volume and rate of infusion of Cholera Saline depends upon the requirements of the patient and the judgement of the physician. It usually varies with age, weight and clinical condition of the patient.

Administration Procedure:

• Check infusion set and infusion solution prior to use
• Pull moderately to tear off the protective cover of the Eurohead
• Hold lightly the Eurohead but not the bag
• Open the flow regulator fully and hold the giving set on the top white area, but not the membrane venting region
• Insert the spike of the administration set to the Eurohead and fit the connector of the administration set firmly to the needle
• Gradually allow the fluid to flow down to the needle tip and close
• Remove the protective cover of the needle
• Locate the venipuncture site and clean the site with an antiseptic solution, and then insert the needle
• Securely tape the puncture site
• Securely tape the wings and tubing
• Start infusion while adjusting drip speed

Since Cholera Saline contains different electrolytes, it should be infused with caution in patients where electrolyte imbalance may cause detrimental effects, e.g. in pregnancy, renal impairment, heart failure, pulmonary congestion, head injury etc. or in patients receiving potassium sparing diuretics.

Should be stored at controlled room temperature.

Cholera Saline contains different electrolytes which are usually depleted in various conditions e.g. diarrhoea, vomiting, profuse sweating etc. So, this saline is indicated in cholera, also in diarrhoea, vomiting, fluid loss, to replenish and restore the normal electrolyte balance of the body.

Intravenous fluid preparations

The volume and rate of infusion of Cholera Saline depends upon the requirements of the patient and the judgement of the physician. It usually varies with age, weight and clinical condition of the patient.

Administration Procedure:

• Check infusion set and infusion solution prior to use
• Pull moderately to tear off the protective cover of the Eurohead
• Hold lightly the Eurohead but not the bag
• Open the flow regulator fully and hold the giving set on the top white area, but not the membrane venting region
• Insert the spike of the administration set to the Eurohead and fit the connector of the administration set firmly to the needle
• Gradually allow the fluid to flow down to the needle tip and close
• Remove the protective cover of the needle
• Locate the venipuncture site and clean the site with an antiseptic solution, and then insert the needle
• Securely tape the puncture site
• Securely tape the wings and tubing
• Start infusion while adjusting drip speed

Since Cholera Saline contains different electrolytes, it should be infused with caution in patients where electrolyte imbalance may cause detrimental effects, e.g. in pregnancy, renal impairment, heart failure, pulmonary congestion, head injury etc. or in patients receiving potassium sparing diuretics.

Should be stored at controlled room temperature.

Phytomenadione (Vitamin K-1) is indicated in following indications-

• Prophylaxis and treatment of haemorrhagic disease in the newborn.
• Haemorrhage or risk of haemorrhage as a result of severe hypoprothrombinemia (i.e. deficiency of clotting factors II, VII, IX and X) of various etiologies, including overdosage of courmarin-type anticoagulants, their combination with phenylbutazone, and other forms of hypovitaminosis K (e.g. in obstructive jaundice as well as liver and intestinal disorders, and after prolonged treatment with antibiotics, sulphonamides or salicylates).
• Prevention and treatment of bleeding due to vitamin K deficiency.

Vitamin-K Preparations

Phytomenadione is a procoagulant factor. As a component of a hepatic carboxylase system, Phytomenadione is involved in the post translational carboxylation of clotting factors II (prothrombin), VII, IX and X and the clotting inhibitors protein C and protein S. Phytomenadione is ineffective in hereditary hypoprothrombinemia or hypoprothrombinemia induced by severe hepatic failure. Lack of Phytomenadione leads to an increased tendency to haemorrhagic disease in the newborn. Phytomenadione administration, which promotes synthesis of the above-mentioned coagulation factors by the liver, can reverse an abnormal coagulation status and bleeding due to Phytomenadione deficiency.

Prophylaxis: Mild Hemorrhage or hemorrhagic tendency: The usual dose for Neonates is 2 mg orally at or just after birth. Then 2 mg on 4^th-5^th day and another 2 mg on 28^th-30^th day orally. If the oral route is unsuitable then 2 mg of drug can be administered by IM or IV route.

Children over 1 year of age: Could be given 5-10 mg orally. A single 1 mg (0.1 ml) dose IM is recommended in children who are not assured of receiving a second oral dose or, in the case of breast-fed children, who are not assured of receiving a third oral dose.

Therapy: Initially, 1 mg by intravenous injection, with further doses as required, based on the clinical picture and coagulation status.

Neonates with special risk factors: Pre-maturity, birth asphyxia (inadequate intake of oxygen by the baby during birth process), obstructive jaundice, inability to swallow, maternal use of anticoagulants or anti-epileptics-

• 1 mg intramuscularly or intravenously at birth or shortly after birth if the oral route is unsuitable.
• Intramuscular and intravenous doses should not exceed 0.4 mg/kg in premature infants weighing less than 2.5 kg.
• The size and frequency of further doses should be based on coagulation status

To ensure a total protection of the newborns, 3 prophylactic doses of Vitamin K should be administered orally following the dosing schedule mentioned above.

There are isolated unconfirmed reports on the possible occurrence of anaphylactoid reactions and venous irritation or phlebitis after parenteral use of Phytomenadione injections.

It is contraindicated in patients with known hypersensitivity to any of its constituents.

Careful monitoring of the coagulation parameters is necessary for patients with severely impaired liver function after administration of Phytomenadione .

Phytomenadione antagonises the effect of coumarin-type anticoagulants. Coadministration of anticonvulsants can impair the action of vitamin K-1.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Phytomenadione (Vitamin K-1) is indicated in following indications-

• Prophylaxis and treatment of haemorrhagic disease in the newborn.
• Haemorrhage or risk of haemorrhage as a result of severe hypoprothrombinemia (i.e. deficiency of clotting factors II, VII, IX and X) of various etiologies, including overdosage of courmarin-type anticoagulants, their combination with phenylbutazone, and other forms of hypovitaminosis K (e.g. in obstructive jaundice as well as liver and intestinal disorders, and after prolonged treatment with antibiotics, sulphonamides or salicylates).
• Prevention and treatment of bleeding due to vitamin K deficiency.

Vitamin-K Preparations

Phytomenadione is a procoagulant factor. As a component of a hepatic carboxylase system, Phytomenadione is involved in the post translational carboxylation of clotting factors II (prothrombin), VII, IX and X and the clotting inhibitors protein C and protein S. Phytomenadione is ineffective in hereditary hypoprothrombinemia or hypoprothrombinemia induced by severe hepatic failure. Lack of Phytomenadione leads to an increased tendency to haemorrhagic disease in the newborn. Phytomenadione administration, which promotes synthesis of the above-mentioned coagulation factors by the liver, can reverse an abnormal coagulation status and bleeding due to Phytomenadione deficiency.

Prophylaxis: Mild Hemorrhage or hemorrhagic tendency: The usual dose for Neonates is 2 mg orally at or just after birth. Then 2 mg on 4^th-5^th day and another 2 mg on 28^th-30^th day orally. If the oral route is unsuitable then 2 mg of drug can be administered by IM or IV route.

Children over 1 year of age: Could be given 5-10 mg orally. A single 1 mg (0.1 ml) dose IM is recommended in children who are not assured of receiving a second oral dose or, in the case of breast-fed children, who are not assured of receiving a third oral dose.

Therapy: Initially, 1 mg by intravenous injection, with further doses as required, based on the clinical picture and coagulation status.

Neonates with special risk factors: Pre-maturity, birth asphyxia (inadequate intake of oxygen by the baby during birth process), obstructive jaundice, inability to swallow, maternal use of anticoagulants or anti-epileptics-

• 1 mg intramuscularly or intravenously at birth or shortly after birth if the oral route is unsuitable.
• Intramuscular and intravenous doses should not exceed 0.4 mg/kg in premature infants weighing less than 2.5 kg.
• The size and frequency of further doses should be based on coagulation status

To ensure a total protection of the newborns, 3 prophylactic doses of Vitamin K should be administered orally following the dosing schedule mentioned above.

There are isolated unconfirmed reports on the possible occurrence of anaphylactoid reactions and venous irritation or phlebitis after parenteral use of Phytomenadione injections.

It is contraindicated in patients with known hypersensitivity to any of its constituents.

Careful monitoring of the coagulation parameters is necessary for patients with severely impaired liver function after administration of Phytomenadione .

Phytomenadione antagonises the effect of coumarin-type anticoagulants. Coadministration of anticonvulsants can impair the action of vitamin K-1.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Bromelain & Trypsin is indicated for inflammatory pains, soft tissue inflammation, edema associated with trauma and surgery such as in gynaecological conditions, breast engorgement, fractures, sprains, injuries, hemorrhoid, anal prolapse

Enzymes

Trypsin is an enzyme. An enzyme is a protein that speeds up a certain biochemical reaction. Trypsin is found in the small intestine. It can also be made from fungus, plants, and bacteria. But it is usually made for commercial purposes from the pancreas of livestock. Trypsin is given to people who lack enzymes needed for digestion. It is also given in combination with bromelain and rutin for treatment of osteoarthritis.

Bromelain is a protein extract derived from the stems of pineapples, although it exists in all parts of the fresh plant and fruit. The extract has a history of folk medicine use. As a culinary ingredient, it may be used as a meat tenderizer. The term "bromelain" may refer to either of two protease enzymes extracted from the plants of the family Bromeliaceae, or it may refer to a combination of those enzymes along with other compounds produced in an extract.

Initially 2 tabs 3 times daily. Maintenance 1 tab 3 times daily preferably before meals

Trypsin seems to be safe when used by healthcare professionals for wound cleaning and healing. It can cause side effects such as pain and burning. Not enough is known about the safety of trypsin for its other uses.

Hypersensitivity.

Allergies: If you are allergic to pineapple, latex, wheat, celery, papain, carrot, fennel, cypress pollen, or grass pollen, you might have an allergic reaction to bromelain.

Surgery: Bromelain might increase the risk of bleeding during and after surgery. Stop using bromelain at least 2 weeks before a scheduled surgery.

There are no known drug interactions and none well documented.

Pregnancy Category-Not Classified. FDA has not yet classified the drug into a specified pregnancy category.

This cream is indicated for the fast relief of minor aches and pains of muscles & joints associated with-

• Joint Pain
• Back Pain
• Arthritic Pain
• Neck & Shoulder Pain
• Sprains
• Strains

Local Antipruritic, Topical Analgesics, Topical anti-inflammatory preparations

This cream is a specially formulated Methyl salicylate and Menthol cream. It penetrates into skin to provide fast relief from pain and stiffness of minor arthritis and muscle aches. This cream is fast-acting, strong medicine that penetrates deep down to provide long-lasting and effective relief. Methyl salicylate has been shown that first-pass metabolism exists in the skin and rapidly hydrolyzing salicylate ester to release the active salicylate in both epidermis and dermis. It alleviates pain and inflammation by inhibiting the synthesis of prostaglandins that occur in inflamed tissues. Menthol increases the penetration of drugs when applied on the skin to give a faster onset of action. It dilates the blood vessels causing a sensation of coldness followed by an analgesic effect.

Adult and children 2 years of age and older: Apply a thin layer to the affected area and gently massage until this cream disappears. Apply to the affected area not more than 3 to 4 times daily.

Redness or irritation may occur, especially in persons with sensitive skin. Adverse reactions possibly involved are mild to moderate local irritation, erythema, rash, desquamation, pruritis and relative local reaction at the application site.

Allergy to salicylate or sensitivity to any of the components. Application to broken skin or raw surfaces is contraindicated.

For external use only. Use only as directed. Do not use with a heating pad. Keep away from children to avoid accidental ingestion. Do not swallow. If swallowed, get medical help or contact a poison control centre immediately. Do not bandage tightly. Keep away from eyes, mucous membranes, broken or irritated skin. If skin redness or excessive irritation develops, pain lasts for more than 10 days or with arthritis-like conditions in children under 12, do not use and call a physician.

Methyl Salicylate is systemically absorbed through the skin in measurable amounts and may increase Warfarin action by affecting Vitamin K metabolism or by displacing warfarin from protein-binding sites.

This medication should be used only if clearly needed during pregnancy or while breast-feeding.

Large amount of topical application may cause absorption through the skin and may cause salicylism. Symptoms of salicylism include tinnitus,hearing loss, nausea, vomiting etc.

It should be stored in a cool and dry place, away from light, temperature not exceeding 30°C. Keep out of reach of children.

This cream is indicated for the fast relief of minor aches and pains of muscles & joints associated with-

• Joint Pain
• Back Pain
• Arthritic Pain
• Neck & Shoulder Pain
• Sprains
• Strains

Local Antipruritic, Topical Analgesics, Topical anti-inflammatory preparations

This cream is a specially formulated Methyl salicylate and Menthol cream. It penetrates into skin to provide fast relief from pain and stiffness of minor arthritis and muscle aches. This cream is fast-acting, strong medicine that penetrates deep down to provide long-lasting and effective relief. Methyl salicylate has been shown that first-pass metabolism exists in the skin and rapidly hydrolyzing salicylate ester to release the active salicylate in both epidermis and dermis. It alleviates pain and inflammation by inhibiting the synthesis of prostaglandins that occur in inflamed tissues. Menthol increases the penetration of drugs when applied on the skin to give a faster onset of action. It dilates the blood vessels causing a sensation of coldness followed by an analgesic effect.

Adult and children 2 years of age and older: Apply a thin layer to the affected area and gently massage until this cream disappears. Apply to the affected area not more than 3 to 4 times daily.

Redness or irritation may occur, especially in persons with sensitive skin. Adverse reactions possibly involved are mild to moderate local irritation, erythema, rash, desquamation, pruritis and relative local reaction at the application site.

Allergy to salicylate or sensitivity to any of the components. Application to broken skin or raw surfaces is contraindicated.

For external use only. Use only as directed. Do not use with a heating pad. Keep away from children to avoid accidental ingestion. Do not swallow. If swallowed, get medical help or contact a poison control centre immediately. Do not bandage tightly. Keep away from eyes, mucous membranes, broken or irritated skin. If skin redness or excessive irritation develops, pain lasts for more than 10 days or with arthritis-like conditions in children under 12, do not use and call a physician.

Methyl Salicylate is systemically absorbed through the skin in measurable amounts and may increase Warfarin action by affecting Vitamin K metabolism or by displacing warfarin from protein-binding sites.

This medication should be used only if clearly needed during pregnancy or while breast-feeding.

Large amount of topical application may cause absorption through the skin and may cause salicylism. Symptoms of salicylism include tinnitus,hearing loss, nausea, vomiting etc.

It should be stored in a cool and dry place, away from light, temperature not exceeding 30°C. Keep out of reach of children.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic actions. In addition to the inhibition of prostaglandin synthesis, it stabilizes lysosomal membranes in vitro and in vivo, inhibits leukotriene synthesis in vitro at high concentrations, and also exhibits antibradykinin activity in vivo. Ketoprofen produces analgesia by inhibiting the synthesis of prostaglandins peripherally and centrally. It has also been suggested that Ketoprofen causes the suppression of prostaglandin synthesis in the CNS (probably in the hypothalamus) leading to its antipyretic effect.

Ketoprofen is rapidly and almost completely absorbed from the GI tract. It is approximately 99% bound to plasma protein, mainly albumin. Following single or multiple oral doses in healthy adults, the elimination half-life of the drug has averaged 1.1-4 hours. It is rapidly and extensively metabolized in the liver, principally via conjugation with glucoronic acid. Following a single oral dose of Ketoprofen in healthy adults, about 50-90% of the drug is excreted in urine and about 1-8% in faeces within 1-5 days ; most urinary excretion occurs within 12-24 hours and most faecal excretion occurs within 24-48 hours. In case of IM injection, peak concentration of approximately 10 mg/L is reached at about 0.5-0.75 hour after a 100 mg dose. The elimination half-life is approximately 1.88 hour.

Anti-inflammatory dosage: The recommended starting dose is 150 to 300 mg/day in 3 divided doses. Once the maintenance dosage has been established (usually 100 to 200 mg/day), the patient may be tried on a twice daily dose regimen. Alternatively, switching to the once daily form at the same dosage may be considered. The recommended maximum daily dose is 300 mg.

Management of pain and primary dysmenorrhea: The usual recommended dose is 25 to 50 mg, every 6 to 8 hours as necessary. The total daily dose should not exceed 300 mg.

The oral forms should be taken with fluids, preferably with food.

Ketoprofen is contraindicated in patients who have a history of hypersensitivity reactions such as asthmatic attacks or other allergic-type reactions to ketoprofen, ASA or other NSAIDs. Severe, rarely fatal, anaphylactic reactions have been reported in such patients. Ketoprofen is also contraindicated in the following cases:

• Severe heart failure
• Active or history of peptic ulcer/hemorrhage
• History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy
• Severe hepatic insufficiency
• Severe renal insufficiency
• Third trimester of pregnancy
• Rectitis or history of proctorrhagia (rectal administration)

Oral Forms: NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated. At the start of treatment, renal function must be carefully monitored in patients with heart failure, cirrhosis and nephrosis, in patients receiving diuretic therapy, in patients with chronic renal impairment, particularly if the patient is elderly. In these patients, administration of ketoprofen may induce a reduction in renal blood flow caused by prostaglandin inhibition and lead to renal decomposition.

Caution is required in patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

Increased risk of atrial fibrillation has been reported in association with the use of NSAIDs.Hyperkalemia may occur, especially in patients with underlying diabetes, renal failure, and/or concomitant treatment with hyperkalemia promoting agents. Potassium levels must be monitored under these circumstances.

As with other NSAIDs, in the presence of an infectious disease, it should be noted that the antiinflammatory, analgesic and the antipyretic properties of ketoprofen may mask the usual signs of infection progression such as fever.

In patients with abnormal liver function tests or with a history of liver disease, transaminase levels should be evaluated periodically, particularly during long-term therapy. Rare cases of jaundice and hepatitis have been described with ketoprofen.

If visual disturbances such a blurred vision occur, treatment should be discontinued. The use of NSAIDs may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of the NSAID should be considered.

Not recommended drug associations Other NSAIDs (including cyclooxygenase-2 selective inhibitors) and high dose salicylates: Increased risk of gastrointestinal ulceration and bleeding. Anticoagulants Increased risk of bleeding.

• Heparin
• Vitamin K antagonists (such as warfarin)
• Platelet aggregation inhibitors (such as ticlopidine, clopidogrel)
• Thrombin inhibitors (such as dabigatran)
• Direct factor Xa inhibitors (such as apixaban, rivaroxaban, edoxaban)

If coadministration is unavoidable, patient should be closely monitored.

• Lithium: Risk of elevation of lithium plasma levels, sometimes reaching toxic levels due to decreased lithium renal excretion. Where necessary, plasma lithium levels should be closely monitored and the lithium dosage levels adjusted during and after NSAID therapy.
• Methotrexate at doses greater than 15mg/week: Increased risk of haematologic toxicity of methotrexate, particularly if administered at high doses (>15 mg/week), possibly related to displacement of protein-bound methotrexate and to its decreased renal clearance.
• Drug associations requiring precautions for use Medicinal products and therapeutic categories that can promote hyperkalemia (i.e. potassium salts, potassium-sparing diuretics, ACE inhibitors and angiotensin II antagonists, NSAIDs, heparins (low molecular-weight or unfractioned), cyclosporin, tacrolimus and trimethoprim): The risk of hyperkalemia can be enhanced when the drugs mentioned above are administered concomitantly.
• Corticosteroids: increased risk of gastrointestinal ulceration or bleeding.
• Diuretics: Patients and particularly dehydrated patients taking diuretics are at a greater risk of developing renal failure secondary to a decrease in renal blood flow caused by prostaglandin inhibition. Such patients should be rehydrated before initiating co-administration therapy and renal function monitored when the treatment is started.
• ACE inhibitors and Angiotensin II Antagonists: In patients with compromised renal function (e.g. dehydrated patients or elderly patients the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure.
• Nicorandil: In patients concomitantly receiving nicorandil and NSAIDs, there is an increased risk for severe complications such as gastrointestinal ulceration, perforation and hemorrhage.
• Cardiac glycosides: A pharmacokinetic interaction between ketoprofen and digoxin has not been demonstrated. However, caution is advised, in particular in patients with renal impairment, since NSAIDs may reduce renal function and decrease renal clearance of cardiac glycosides.
• Cyclosporin: Increased risk of nephrotoxicity.
• Tacrolimus: Increased risk of nephrotoxicity.
• Methotrexate at doses lower than 15mg/week: During the first weeks of combination treatment, full blood count should be monitored weekly. If there is any alteration of the renal function or if the patient is elderly, monitoring should be done more frequently.
• Pentoxifylline: There is an increased risk of bleeding. More frequent clinical monitoring and monitoring of bleeding time is required.
• Tenofovir: Concomitant administration of tenofovir disoproxil fumarate and NSAIDs may increase the risk of renal failure.
• Drug associations to be taken into account Antihypertensive agents (beta-blockers, angiotensin converting enzyme inhibitors, diuretics): Risk of decreased antihypertensive potency (inhibition of vasodilator prostaglandins by NSAIDs).
• Thrombolytics: Increased risk of bleeding. Probenecid: Concomitant administration of probenecid may markedly reduce the plasma clearance of ketoprofen.
• Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.

During the first and second trimester: As the safety of ketoprofen in pregnant women has not been evaluated, the use of Ketoprofen during the first and second trimester of pregnancy should be avoided. During the third trimester of pregnancy: Prodenid is contraindicated during the last trimester of pregnancy. Ketoprofen is not recommended in nursing mothers.

Elderly: It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose.

Hepatic impairment: These patients should be carefully monitored and kept at the minimal effective daily dosage.

Renal impairment: It is advisable to reduce the initial dosage and maintain such patients on the minimal effective dose.

Cases of overdose have been reported with doses up to 2.5 g of ketoprofen. In most instances, the symptoms observed have been benign and limited to lethargy, drowsiness, nausea, vomiting and epigastric pain. There are no specific antidotes to ketoprofen overdosages. In cases of suspected massive overdosages, a gastric lavage is recommended and symptomatic and supportive treatment should be instituted to compensate for dehydration, to monitor urinary excretion and to correct acidosis, if present. If renal failure is present, hemodialysis may be useful to remove circulating drug.

Protect from light. Store below 30°C. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

Alpha adrenoceptor blocking drugs, Beta-adrenoceptor blocking drugs, Beta-blockers

Carvedilol is a cardiovascular drug whose main pharmacological action is non-selective antagonism of β-adrenergic receptors but which also possesses appreciable a-adrenergic antagonistic activity. It also has antiproliferative properties and is a scavenger of reactive free oxidant radicals. It is used in the treatment of hypertension, angina pectoris and congestive heart failure.

In hypertension: initially, 12.5 mg once daily, increased after 2 days to the usual dose of 25 mg once daily; if necessary the dose may be further increased at intervals of at least 2 weeks to maximum 50 mg daily in single or divided doses. In elderly patients, the initial dose of 12.5 mg daily may provide satisfactory control.

In angina pectoris: the recommended dose for initiation of therapy is 12.5 mg twice daily for the first 2 days. Thereafter, the recommended dosage is 25 mg twice daily. For elderly patients, the maximum daily dose is 50 mg daily in divided doses.

In heart failure: initially, 3.125 mg twice daily (with food) may be given, the dose may be increased at intervals of at least 2 weeks to 6.25 mg twice daily, then to 12.5 mg twice daily, then to 25 mg twice daily. The dose may be increased to the highest dose tolerated, maximum 25 mg twice daily in patients less than 85 kg body-weight and 50 mg twice daily in patients over 85 kg.

Postural hypotension, dizziness, headache, fatigue, gastro-intestinal disturbances, bradycardia; occasionally diminished peripheral circulation, peripheral oedema and painful extremities, dry mouth, dry eyes, eye irritation or disturbed vision, impotence, disturbances of micturition, influenza-like symptoms, rarely angina, AV block, exacerbation of intermittent claudication or Raynaud's phenomenon, allergic skin reactions, exacerbation of psoriasis, nasal stuffiness, wheezing, depressed mood, sleep disturbances, paresthesia, heart failure, changes in liver enzymes, thrombocytopenia, leukopenia are also reported.

Carvedilol is contraindicated in patients with decompensated heart failure requiring intravenous inotropic therapy, bronchial asthma or related bronchospastic conditions, second or third-degree AV block, sick sinus syndrome (unless a permanent pacemaker is in place), cardiogenic shock or severe bradycardia.

Take caution in hepatic impairment and in heart failure monitor clinical status for 2-3 hours after initiation and after increasing each dose. Before increasing dose ensure that the renal function and heart failure are not deteriorating

Digoxin: In normal healthy volunteers a single dose of carvedilol taken together with a single dose of digoxin resulted in significantly increased levels of digoxin 24 hours later. Patients with congestive heart failure stabilized on digoxin have been given carvedilol concomitantly without any adverse effects. Increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing the dose of carvedilol.

Rifampin: Pretreatment with rifampin resulted in a 60% decrease in Cmax and AUC.

Warfarin: Carvedilol did not alter the in vitro plasma protein binding of warfarin.

Clonidine: β-receptor antagonists potentiate the pressor reaction which may follow the sudden withdrawal of treatment with clonidine although, in theory, the a-blocking action of carvedilol should modify the pressure rise.

Carvedilol should not be used during breast-feeding, since no studies have been performed in lactating women and animal studies have shown that carvedilol is excreted in breast milk. Safety and efficacy in children have not been established with carvedilol. Carvedilol should not be used during pregnancy as no studies have been performed in this group. Animal studies have shown that carvedilol crosses the placental barrier. No information is available on the safety and efficacy of Carvedilol use in neonates.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.