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Miconazole Nitrate oral gel is indicated-

• For the treatment of oral and gastrointestinal candidiasis.
• For eradication of fungal colonization in the mouth and gastrointestinal tract.
• For the treatment of super infections due to gram-positive bacteria.

Aural Anti-fungal preparations

Pharmacodynamics: Miconazole possesses an antifungal activity against the common dermatophytes and yeasts as well as an antibacterial activity against certain gram-positive bacilli and cocci. Its activity is based on the inhibition of a demethylation step in the ergosterol biosynthesis. Ergosterol, the end-product of the biosynthetic pathway and the main sterol in yeast and fungi. The disruption in production of ergosterol disrupts the fungal cell membrane, causing holes to appear in it. These holes allow the essential constituents of the fungal cells to leak out and ultimately the fungal cells die.

Pharmacokinetics: The oral bioavailability of Miconazole is low (25-30%) because there is little absorption of Miconazole from the intestinal tract. Miconazole is systemically absorbed after administration as the oral gel. Absorbed Miconazole is bound to plasma proteins (88.2%), primarily to serum albumin and red blood cells (10.6%). The absorbed portion of Miconazole oral gel is largely metabolized; less than 1% of the administered dose is excreted unchanged in the urine. The terminal plasma half-life is 20-25 hours in most patients. The elimination half-life of Miconazole is similar in any renal impaired patient.

Oropharyngeal candidosis-

• Infants 4-24 months: 1.25 ml (1⁄4 measuring spoon) of gel, applied 4 times day after meals.
• Adult and children 2 years of age and older: 2.5 ml (1⁄2 measuring spoon) of gel, applied 4 times a day after meals.

Gastrointestinal tract candidosis-

• Infants (4 months of age or above): Children and adults who have difficulty swallowing tablets: 20 mg per kg body weight per day, in four divided doses. The daily dose should not exceed 250 mg (10 ml gel) four times daily.

Missed Dose: Apply the missed dose as soon as you remember. In case of next dosing time, omit the missed
dose and continue your usual course.

In case of localized lesions of the mouth, a small amount of gel may be applied 2-4 times a day directly to the affected area with a clean finger. For best results, Miconazole oral gel should be kept in contact with the affected area as long as possible. The treatment should be continued for at least a week after symptoms have disappeared. For oral candidosis, dental prosthesis should be removed at night and brushed with the gel.

Occasionally nausea and vomiting, diarrhea with long term use and rarely allergic reactions.

Miconazole is contraindicated in patients with known hypersensitivity to the active ingredient.

If the concomitant use of Miconazole and anticoagulant is considered, the anti-coagulant effect should be monitored and titrated. Miconazole and phenytoin plasma level should also be monitored when used concomitantly. In infants and young children, caution must be taken to ensure that the gel does not obstruct the throat.

There is no information regarding the safety of Miconazole oral gel during pregnancy. So Miconazole oral gel should be avoided in pregnant women if possible or the potential hazards should be balanced against the possible benefits. As many drugs are excreted in human milk, caution should be exercised when Miconazole is administered to a nursing woman.

Accidental overdosage may cause vomiting and diarrhea. Treatment is symptomatic and supportive. A specific antidote is not available.

keep in a dry place away from light and heat. Keep out of the reach of children.

Immunological Chemotherapy, Immunosuppressant

Mechanism of Action: Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (MPA). MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis. The mechanism by which MPA inhibits the enzymatic activity of IMPDH appears to be related to the ability of MPA to structurally mimic both nicotinamide adenine dinucleotide cofactor and a catalytic water molecule. This prevents the oxidation of IMP to xanthose-5’-monophosphate which is the committed step in de novo guanosine nucleotide biosynthesis. MPA has more potent cytostatic effects on lymphocytes than on other cells because T- and B lymphocytes are critically dependent for their proliferation on de novo synthesis of purines whereas other cell types can utilize salvage pathways.

Pharmacodynamics: Mycophenolic acid, the active metabolite of mycophenolate mofetil, is a non-competitive, reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH). Inhibition of IMPDH blocks the de novo synthesis of guanosine nucleotides which are necessary substrates for DNA and RNA synthesis. Unlike other cell types which can use the salvage pathway, B and T lymphocytes are dependent upon the de novo pathway for the generation of guanosine. Data from in vitro studies indicate that mycophenolic acid and/or mycophenolate mofetil inhibit mixed lymphocyte responses and human peripheral blood lymphocyte proliferation induced by a variety of mitogens and antigens. Mycophenolic acid decreases intracellular pools of guanosine triphosphate (GTP) and deoxyguanosine triphosphate (dGTP) in mitogen-stimulated human peripheral blood monocytes or T lymphocytic cell lines but has no effect on GTP concentrations in human neutrophils.

Transplant patients:
Standard dosage for prophylaxis of renal rejection

• Adults: A dose of 1 g administered orally twice a day (daily dose of 2 g) is recommended for use in renal transplant patients.
• Children (aged 3 months to 18 years): Patients with a body surface area of 1.25 to 1.5 m² may be prescribed Mycophenolate Mofetil Tablets at a dose of 750 mg twice daily (1.5 g daily dose). Patients with a body surface area >1.5 m² may be prescribed Mycophenolate Mofetil tablets at a dose of 1 gm twice daily (2 g daily dose).

Standard dosage for prophylaxis of cardiac rejection-

• Adults: A dose of 1.5 g administered orally (over not less than 2 hour) twice a day (daily dose of 3 g) is recommended for use in cardiac transplant patients.
• Children: no data are available for pediatric cardiac transplant patients.

Standard dosage for prophylaxis of hepatic rejection-

• Adults: A dose of 1.5 g orally twice a day (daily dose of 3 g) is recommended for use in hepatic transplant patients
• Children: no data are available for pediatric hepatic transplant patients.

Standard dosage for treatment of first or refractory renal rejection-

• Adults: A dose of 1.5 g administered orally twice a day (daily dose of 3 g) is recommended for management of first or refractory rejection.
• Children: no data are available for the treatment of first or refractory renal rejection in pediatric renal transplant patients.

Lupus nephritis patients:
Standard Dosage for Induction Therapy-

• Adults: A dose of 750 mg-1.5 g administered orally twice a day (daily dose of up to 3 g) is recommended
• Children: A dose of 600 mg/m² administered orally twice a day (up to a maximum of 2 g daily) is recommended

Standard Dosage for Maintenance Therapy-

• Adults: A dose of 500 mg-1 g administered orally twice a day is recommended
• Children: A dose of 300 mg/m² administered orally twice a day is recommended

Mycophenolate Mofetil should be used in combination with corticosteroids. Doses should be introduced gradually and adjusted according to clinical response. Therapeutic drug monitoring could help prevent sub-therapeutic exposure (Cmin≥3.0 mg/L or inter-dose AUC ≥35 h*mg/L).

The principal adverse reactions associated with the administration of Mycophenolate Mofetil includes diarrhea, leukopenia, sepsis, gastrointestinal candidiasis, urinary tract infection, herpes simplex, vomiting and there is evidence of a higher frequency of certain types of infections eg. opportunistic infections.

Mycophenolic acid is contraindicated in patients with a hypersensitivity to mycophenolic acid, or to any of its excipients. Mycophenolic acid is contraindicated during pregnancy due to its mutagenic and teratogenic potential. Mycophenolic acid is contraindicated in women who are breastfeeding.

Mycophenolic acid tablets are used with caution because it-

• Can increase new or reactive viral infections. Such infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation, or infections caused by polyomaviruses.
• Can cause blood dyscrasias including pure red cell aplasia (PRCA).
• Can cause serious GI tract complications (gastrointestinal bleeding, perforations and ulcers).
• May increase the risk of developing lymphomas and other malignancies, particularly of the skin.
• Use of live vaccines should be avoided during treatment with Mycophenolic acid.
• Patients should not donate blood during therapy.

Caution should be exercised with concomitant administration of Antacids, Azathioprine, Cyclosporin, Rifampin, Sevelamer, Cholestyramine, Acyclovir, Metronidazole, Hormonal contraceptives as these medicines may decrease Mycophenolic acid concentration.

Mycophenolate Mofetil is contraindicated in pregnancy and during breastfeeding. The safe use of Mycophenolate Mofetil during labor and delivery has not been established.

Geriatric population: Geriatric patients may be at an increased risk of adverse events such as certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal hemorrhage and pulmonary edema, compared with younger individuals.

In many of these cases no adverse events were reported. It is expected that an overdose of mycophenolate mofetil could possibly result in over suppression of the immune system and increase susceptibility to infections and bone marrow suppression. If neutropenia develops, dosing with Mycophenolate Mofetil should be interrupted or the dose reduced.

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

Fluconazole is indicated for the treatment of vaginal candidiasis, oropharyngeal & esophageal candidiasis and cryptococcal meningitis. It is also effective for the treatment of urinary tract infection caused by candida, peritonitis and systemic candida infections (including candidemia, disseminated candidiasis and pneumonia).

Drugs for subcutaneous and mycoses

Fluconazole is a triazole antifungal agent. It is a potent inhibitor of fungal cytochrome P-450 dependent enzymes. Cytochrome P-450 enzyme system is essential component of fungal cell membrane which is responsible for the synthesis of ergosterol.

Adult (oral)-

• Vaginal candidiasis: 150 mg as a single dose.
• Oropharyngeal candidiasis: 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of this infection generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.
• Esophageal candidiasis: 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used. Patients should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.
• Systemic candida infections: Optimal therapeutic dosage and duration of therapy have not been established. Sometimes, doses of up to 400 mg daily have been used.
• Urinary tract infections caused by candida and peritonitis: 50-200 mg daily have been used.
• Cryptococcal meningitis: 400 mg on the first day, followed by 200 mg once daily.
• Prophylaxis in patients undergoing bone marrow transplantation: 400 mg once daily.

Child (oral):

• Doses of 3-6 mg/kg daily have been used. Doses up to 12 mg/kg is recommended.

Intravenous-

• Adult: Invasive candidal infections including candidaemia and disseminated candidiasis and cryptococcal infections including meningitis, by IV, 400 mg initially then 200 mg daily, increased if necessary to 400 mg daily, treatment continued according to response (at least 6-8 weeks for cryptococcal meningitis)
• Child: 6-12 mg/kg daily (every 72 hours in neonate up to 2 weeks old, every 48 hours in neonate 2-4 weeks old); maximum 400 mg daily. Prevention of relapse of cryptococcal meningitis, by IV, 100-200 mg daily.

Fluconazole is well tolerated. Most common side effects of using Fluconazole includes nausea, vomiting, abdominal pain, diarrhoea, headache and skin rash.

Fluconazole should not be used in patients with known hypersensitivity to Fluconazole or to related triazole compounds.

Fluconazole should be administered with caution to patients having proarrhythmic conditions.

Concomitant use of cyclosporin or phenytoin with Fluconazole increases the plasma level of cyclosporin or phenytoin. Concomitant use of Fluconazole & warfarin prolongs the prothrombin time. Rifampicin level is decreased when used with Fluconazole.

US FDA Pregnancy category of Fluconazole is C. So, Fluconazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Calcium-channel blockers

Cilnidipine is a dihydropyridine calcium-channel blocker. Cilnidipine binds to the dihydropy-ridine binding sites of the L-type voltage dependent calcium channel and inhibits Ca²⁺ influx across the cell membranes of vascular smooth muscle cells via this channel, consequently vascular smooth muscle is relaxed, causing vasodilation. Cilnidipine inhibits Ca²⁺ influx via N-type voltage dependent calcium channels in the sympathetic nerve cell membrane. The inhibition of Ca²⁺ influx via N-type voltage dependent calcium channel was observed over a similar range of drug concentrations to those inhibiting L-type voltage dependent Ca²⁺ channels. Consequently, release of norepinephrine from sympathetic nerve terminals would be inhibited. Cilnidipine is considered to suppress the reflex increase in heart rate after blood pressure reduction.

Adults: 5-10 mg once daily after breakfast. Maximum dose: 20 mg once daily.

Pediatric use: The safety of Cilnidipine in pediatric patients has not been established.

Elderly use: Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose (5 mg).

The most common side effects of Cilnidipine are: Dizziness; flushing; headache; hypotension; peripheral oedema; palpitations; GI disturbances; increased micturition frequency; lethargy; eye pain; depression.

Cilnidipine is contraindicated in patients with known sensitivity to Cilnidipine or any of the excipients or patients having cardiogenic shock, recent MI or acute unstable angina and severe aortic stenosis.

Cilnidipine should be administered with care in the following patients: patients with serious hepatic dysfunction, patients with a history of serious adverse reactions to calcium antagonists. During the discontinuation, the dosage should be gradually decreased under close observation.

Other anti-hypertensive, antipsychotics that cause hypotension, quinidine, carbamazepine, phenytoin, rifampicin, cimetidine, erythromycin.

Cilnidipine should not be administered in pregnant woman or woman having possibilities of being pregnant. It is also advisable to avoid the administration of Cilnidipine to nursing mothers. However, if the administration is indispensable, the patient should be instructed to discontinue lactation.

Store below 30°C, protected from light and moisture. Keep away from reach out of the children.

Calcium-channel blockers

Cilnidipine is a dihydropyridine calcium-channel blocker. Cilnidipine binds to the dihydropy-ridine binding sites of the L-type voltage dependent calcium channel and inhibits Ca²⁺ influx across the cell membranes of vascular smooth muscle cells via this channel, consequently vascular smooth muscle is relaxed, causing vasodilation. Cilnidipine inhibits Ca²⁺ influx via N-type voltage dependent calcium channels in the sympathetic nerve cell membrane. The inhibition of Ca²⁺ influx via N-type voltage dependent calcium channel was observed over a similar range of drug concentrations to those inhibiting L-type voltage dependent Ca²⁺ channels. Consequently, release of norepinephrine from sympathetic nerve terminals would be inhibited. Cilnidipine is considered to suppress the reflex increase in heart rate after blood pressure reduction.

Adults: 5-10 mg once daily after breakfast. Maximum dose: 20 mg once daily.

Pediatric use: The safety of Cilnidipine in pediatric patients has not been established.

Elderly use: Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose (5 mg).

The most common side effects of Cilnidipine are: Dizziness; flushing; headache; hypotension; peripheral oedema; palpitations; GI disturbances; increased micturition frequency; lethargy; eye pain; depression.

Cilnidipine is contraindicated in patients with known sensitivity to Cilnidipine or any of the excipients or patients having cardiogenic shock, recent MI or acute unstable angina and severe aortic stenosis.

Cilnidipine should be administered with care in the following patients: patients with serious hepatic dysfunction, patients with a history of serious adverse reactions to calcium antagonists. During the discontinuation, the dosage should be gradually decreased under close observation.

Other anti-hypertensive, antipsychotics that cause hypotension, quinidine, carbamazepine, phenytoin, rifampicin, cimetidine, erythromycin.

Cilnidipine should not be administered in pregnant woman or woman having possibilities of being pregnant. It is also advisable to avoid the administration of Cilnidipine to nursing mothers. However, if the administration is indispensable, the patient should be instructed to discontinue lactation.

Store below 30°C, protected from light and moisture. Keep away from reach out of the children.

Central Depolarizing muscle relaxants, Centrally acting Skeletal Muscle Relaxants

Tolperisone Hydrochloride is a centrally acting muscle relaxant, which acts on the central nervous system and used mainly for the treatment of elevated muscle tone and tension as well as for certain circulation problems in the extremities.

The recommended dose is as follows:

• Adult: 50-150 mg three times daily according to the individual requirement and tolerance of the patient.
• Children (from 3 months to 6 years): 5 mg/kg/day in three divided doses.
• Children (from 6 to 14 years): 2-4 mg/kg/day in three divided doses. or, as directed by the registered physician.

Possible side-effects include sometimes muscular weakness, headache, nausea, vomiting and rarely hypersensitivity reactions (itching, redness of the skin, skin rash) may occur.

It is contraindicated in patients with a history of hypersensitivity to any component of the product, myasthenia gravis and nursing mother.

In case of children, the prescribed dose and duration of treatment should closely be observed.

Concomitant use of methocarbamol with Tolperisone Hydrochloride has been reported to cause disturbance of visual accommodation.

Tolperisone Hydrochloride should be used in pregnancy according to the physician's advice. It should not be used during breast feeding.

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

Cyclopentolate is used mainly to produce mydriasis and cycloplegia for diagnostic purposes.

Anticholinergics

Cyclopentolate is an anticholinergic agent that induces relaxation of the sphincter of the iris and the ciliary muscles. When applied topically to the eyes, it causes a rapid, intense cycloplegic and mydriatic effect that is maximal in 15 to 60 minutes; recovery usually occurs within 24 hours. The cycloplegic and mydriatic effects are slower in onset and longer in duration in patients who have dark pigmented irises.

To produce mydriasis and cycloplegia for diagnostic purposes, in adults and children over 1 year: 1 drop instilled in the eye(s), followed by a second drop 5 minutes later, if necessary. Drops should be administered 40 to 50 minutes prior to the procedure. To minimize systemic absorption, finger pressure should be applied to the lacrimal sac for 2 to 3 minutes following administration. Alternatively, the eyelids should be kept closed for 2 to 5 minutes following installation. Patients with heavily pigmented irises may require larger doses. Complete recovery from mydriasis and cycloplegia should occur within 24 hours.

Use in children: Infants and young children and children with blond hair or blue eyes may be especially sensitive to the effects of cyclopentolate, increasing the chance of side effects during treatment. Use of cyclopentolate in children has been associated with psychotic reactions and behavioral disturbances.

Blinding acute angle-closure glaucoma and raised intraocular pressure may occur during cyclopentolate therapy. The mydriasis may be reduced by the intraocular application of pilocarpine, physostigmine or isoflurophate. Transient burning sensation of the eye is more likely with the 0.5% solution. Systemic effects, resulting from excessive absorption from mucosal surfaces or from ingestion of the drug, may include xerostomia, flushing, tachycardia and urinary retention. More severe systemic effects are tachypnea, scarlatiniform rash, delirium, psychosis, fever, stupor, coma, respiratory failure and death.

Cyclopentolate is contraindicated in patients with angle-closure glaucoma or in patients with shallow anterior chambers. Cyclopentolate should not be used in patients, especially children, who have previously experienced a severe systemic reaction to the drug, or in patients with hypersensitivity to any component of a cyclopentolate formulation.

Cyclopentolate may cause increased intraocular pressure. Angle-closure glaucoma may be induced by cyclopentolate in patients with higher susceptibility to increased intraocular pressure including the elderly and individuals with shallow anterior chambers.

Cyclopentolate may cause an increase in intraocular pressure which if sustained, can potentially lead to irreversible loss of vision. The drug should be discontinued and the physician consulted immediately if eye pain, blurring of vision, rapid pulse or dizziness occurs. Patients may require the use of dark glasses following the application of cyclopentolate, due to photophobia associated with mydriasis. Patients should be advised to contact their physician if blurred vision and photophobia continue for more than 48 hours after discontinuing cyclopentolate. Systemic absorption of topical cyclopentolate from the nasal mucosal surfaces may result in systemic adverse effects. This is particularly the case in children, who are most susceptible to the drug's adverse effects. If signs of systemic toxicity appear, such as dry mouth, tachycardia or dizziness, the dosage schedule should be reduced or the drug discontinued.

Cyclopentolate may affect the action of concomitantly administered drugs such as: antihistamines, isoniazid, MAO inhibitors, phenothiazines, procainamide, disopyramide, propranolol, quinidine and tricyclic antidepressants. Anticholinergic agents, such as cyclopentolate, antagonize miosis and ciliary body contraction induced by cholinesterase inhibitors and cholinergic agonists.

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

Atropine is indicated for Non ulcer dyspepsia, Irritable bowel syndrome, Diverticular disease, Bradycardia, Organophosphorus poisoning, Premedication in anesthesia, Poisoning or overdosage with compound having muscarinic actions, Ophthalmic Inflammatory eye disorders, Eye refraction.

Anticholinergics (antimuscarinics)/ Anti-spasmodics, Mydriatic and Cycloplegic agents

Atropine binds to and inhibit muscarinic acetylcholine receptors, producing a wide range of anticholinergic effects. Atropine is an anticholinergic agent which competitively blocks the muscarinic receptors in peripheral tissues such as the heart, intestines, bronchial muscles, iris and secretory glands. Some central stimulation may occur. Atropine abolishes bradycardia and reduces heart block due to vagal activity. Smooth muscles in the bronchi and gut are relaxed while glandular secretions are reduced. It also has mydriatic and cycloplegic effect.

Adult:

• IV: Bradycardia: 500 mcg every 3-5 mins. Total: 3 mg.
• IV/IM: Organophosphorus poisoning: 2 mg every 10-30 mins until muscarinic effects disappear or atropine toxicity appears.
• IM/SC: Premedication in anesthesia: 300-600 mcg 30-60 mins before anesthesia.
• IV/IM/SC: Poisoning or overdosage with compound having muscarinic actions: 0.6-1 mg, repeat 2 hrly.
• Ophthalmic: Inflammatory eye disorders: As 0.5-1% solution: 1-2 drops 4 times/day.
• Ophthalmic: refraction: 1% solution 1 drop twice daily for 1-2 days before procedure.
• Oral: Non ulcer dyspepsia, Irritable bowel syndrome, Diverticular disease: 0.6-1.2 mg as a single dose at bedtime.

Usual Pediatric Dose for Anesthesia:

• 7 to 16 pounds: 0.1 mg, IV, IM, or subcutaneously
• 17 to 24 pounds: 0.15 mg, IV, IM, or subcutaneously
• 24 to 40 pounds: 0.2 mg, IV, IM, or subcutaneously
• 40 to 65 pounds: 0.3 mg, IV, IM, or subcutaneously
• 65 to 90 pounds: 0.4 mg, IV, IM, or subcutaneously
• Over 90 pounds: 0.4 to 0.6 mg, IV, IM, or subcutaneously

Injection: Dry mouth, dysphagia, constipation, flushing and dryness of skin, tachycardia, palpitations, arrhythmias, mydriasis, photophobia, cycloplegia, raised intraocular pressure. Toxic doses cause tachycardia, hyperpyrexia, restlessness, confusion, excitement, hallucinations, delirium and may progress to circulatory failure and resp depression.

Eye drops or ointment: Systemic toxicity esp in children, on prolonged use may lead to irritation, hyperaemia, oedema and conjunctivitis. Increased intraocular pressure.

Glaucoma, chronic respiratory disease, sick sinus syndrome, thyrotoxicosis, cardiac failure, pyloric stenosis, prostatic hypertrophy.

Reflux oesophagitis; elderly; infants and children; Pregnancy.

Additive anticholinergic effects with quinidine, antidepressants and some antihistamines.

Pregnancy Category C. Animal reproduction studies have not been conducted with atropine. It also is not known whether atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. Atropine should be given to a pregnant woman only if clearly needed.

May cause hyperthermia, hypertension, increased respiratory rate, nausea and vomiting. May also lead to CNS stimulation. Severe intoxication may lead to CNS depression, coma, respiratory failure and death.

Store atropine at room temperature between 20 to 25° C. Store away from heat, moisture, and light. Keep atropine out of the reach of children.

Atropine is indicated for Non ulcer dyspepsia, Irritable bowel syndrome, Diverticular disease, Bradycardia, Organophosphorus poisoning, Premedication in anesthesia, Poisoning or overdosage with compound having muscarinic actions, Ophthalmic Inflammatory eye disorders, Eye refraction.

Anticholinergics (antimuscarinics)/ Anti-spasmodics, Mydriatic and Cycloplegic agents

Atropine binds to and inhibit muscarinic acetylcholine receptors, producing a wide range of anticholinergic effects. Atropine is an anticholinergic agent which competitively blocks the muscarinic receptors in peripheral tissues such as the heart, intestines, bronchial muscles, iris and secretory glands. Some central stimulation may occur. Atropine abolishes bradycardia and reduces heart block due to vagal activity. Smooth muscles in the bronchi and gut are relaxed while glandular secretions are reduced. It also has mydriatic and cycloplegic effect.

Adult:

• IV: Bradycardia: 500 mcg every 3-5 mins. Total: 3 mg.
• IV/IM: Organophosphorus poisoning: 2 mg every 10-30 mins until muscarinic effects disappear or atropine toxicity appears.
• IM/SC: Premedication in anesthesia: 300-600 mcg 30-60 mins before anesthesia.
• IV/IM/SC: Poisoning or overdosage with compound having muscarinic actions: 0.6-1 mg, repeat 2 hrly.
• Ophthalmic: Inflammatory eye disorders: As 0.5-1% solution: 1-2 drops 4 times/day.
• Ophthalmic: refraction: 1% solution 1 drop twice daily for 1-2 days before procedure.
• Oral: Non ulcer dyspepsia, Irritable bowel syndrome, Diverticular disease: 0.6-1.2 mg as a single dose at bedtime.

Usual Pediatric Dose for Anesthesia:

• 7 to 16 pounds: 0.1 mg, IV, IM, or subcutaneously
• 17 to 24 pounds: 0.15 mg, IV, IM, or subcutaneously
• 24 to 40 pounds: 0.2 mg, IV, IM, or subcutaneously
• 40 to 65 pounds: 0.3 mg, IV, IM, or subcutaneously
• 65 to 90 pounds: 0.4 mg, IV, IM, or subcutaneously
• Over 90 pounds: 0.4 to 0.6 mg, IV, IM, or subcutaneously

Injection: Dry mouth, dysphagia, constipation, flushing and dryness of skin, tachycardia, palpitations, arrhythmias, mydriasis, photophobia, cycloplegia, raised intraocular pressure. Toxic doses cause tachycardia, hyperpyrexia, restlessness, confusion, excitement, hallucinations, delirium and may progress to circulatory failure and resp depression.

Eye drops or ointment: Systemic toxicity esp in children, on prolonged use may lead to irritation, hyperaemia, oedema and conjunctivitis. Increased intraocular pressure.

Glaucoma, chronic respiratory disease, sick sinus syndrome, thyrotoxicosis, cardiac failure, pyloric stenosis, prostatic hypertrophy.

Reflux oesophagitis; elderly; infants and children; Pregnancy.

Additive anticholinergic effects with quinidine, antidepressants and some antihistamines.

Pregnancy Category C. Animal reproduction studies have not been conducted with atropine. It also is not known whether atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. Atropine should be given to a pregnant woman only if clearly needed.

May cause hyperthermia, hypertension, increased respiratory rate, nausea and vomiting. May also lead to CNS stimulation. Severe intoxication may lead to CNS depression, coma, respiratory failure and death.

Store atropine at room temperature between 20 to 25° C. Store away from heat, moisture, and light. Keep atropine out of the reach of children.

For mydriasis and cycloplegia for diagnostic procedure, for the treatment of acute and subacute iridocyclitis, chronic iridocyclitis, Adhesions and disruptions of iris and ciliary body, Sclera and iris operations

Mydriatic and Cycloplegic agents

Tropicamide binds to and blocks the receptors in the muscles of the eye (muscarinic receptor M4). Tropicamide acts by blocking the responses of the iris sphincter muscle to the iris and ciliary muscles to cholinergic stimulation, producing dilation of the pupil and paralysis of the ciliary muscle.

For refraction: Instill one or two drops of 1% solution in the eye(s), repeated in five minutes. If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect.

For examination of fundus: Instill one or two drops of 0.5% solution 15 to 20 minutes prior to examination. Individuals with heavily pigmented irides may require higher strength or more doses.

Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of tropicamide. Increased intraocular pressure has been reported following the use of mydriatics. Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide.

Contraindicated in persons showing hypersensitivity to any component of this preparation.

The lacrimal sac should be compressed by digital pressure for 2-3 minutes after instillation to avoid excessive systemic absorption.

Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

Pregnancy Category C. Tropicamide should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when tropicamide is administered to a nursing woman.

Store at 15° to 25°C . Do not refrigerate or store at high temperatures. Keep container tightly closed.

For mydriasis and cycloplegia for diagnostic procedure, for the treatment of acute and subacute iridocyclitis, chronic iridocyclitis, Adhesions and disruptions of iris and ciliary body, Sclera and iris operations

Mydriatic and Cycloplegic agents

Tropicamide binds to and blocks the receptors in the muscles of the eye (muscarinic receptor M4). Tropicamide acts by blocking the responses of the iris sphincter muscle to the iris and ciliary muscles to cholinergic stimulation, producing dilation of the pupil and paralysis of the ciliary muscle.

For refraction: Instill one or two drops of 1% solution in the eye(s), repeated in five minutes. If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect.

For examination of fundus: Instill one or two drops of 0.5% solution 15 to 20 minutes prior to examination. Individuals with heavily pigmented irides may require higher strength or more doses.

Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of tropicamide. Increased intraocular pressure has been reported following the use of mydriatics. Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide.

Contraindicated in persons showing hypersensitivity to any component of this preparation.

The lacrimal sac should be compressed by digital pressure for 2-3 minutes after instillation to avoid excessive systemic absorption.

Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

Pregnancy Category C. Tropicamide should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when tropicamide is administered to a nursing woman.

Store at 15° to 25°C . Do not refrigerate or store at high temperatures. Keep container tightly closed.

Preparations for Ophthalmic diagnosis

Tropicamide binds to and blocks the receptors in the muscles of the eye (muscarinic receptor M4). Tropicamide acts by blocking the responses of the iris sphincter muscle to the iris and ciliary muscles to cholinergic stimulation, producing dilation of the pupil and paralysis of the ciliary muscle.

Phenylephrine Hydrochloride is a selective alpha-1 agonist, which causes mydriasis without cycloplegia. It tends to reduce intraocular lesion by vasoconstrictor action.

Uveitis: 1-2 drops bid-qid or as required.

Diagnostic purpose/Pre-operative purpose: Instill 1-2 drops in the eye(s) 15-20 minutes before examination. If examination is not conducted within 20–30 minutes, an additional drop may be placed in the eye(s) to prolong the effect.

Elevated IOP (occasionally), stinging, blurred vision, tachycardia, photophobia, headache, parasympathetic stimulation and allergic reactions. Systemic effects include arrhythmias, hypertension and coronary artery spasm.

This medication is contraindicated in these following cases

• Patients with hypersensitivity to any of the components and narrow angles or narrow angle glaucoma.
• Low birth weight infants and some elderly adults with severe arteriosclerotic cardiovascular or cerebrovascular disease.
• During intraocular operative procedures when the corneal epithelial barrier has been disturbed.

Caution should be taken when administered with, or upto 21days after administration of monoamine oxidase (MAO) inhibitors as exaggerated adrenergic effects may result.

The possibility of psychotic reactions and behavioral disturbances should be considered in patients who are hypersensitive to anticholinergic drugs.

Use with extreme caution in infants.

Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine or ophthalmic cholinesterase inhibitors.

The safety of this medication during pregnancy or lactation has not been established.

Excessive use in children and in certain susceptible individuals may produce systemic toxic symptoms.

Keep out of the reach of children. Store in a cool, dry place, away from heat and direct light. Do not use more than 4 weeks after opening. 

Atropine is indicated for Non ulcer dyspepsia, Irritable bowel syndrome, Diverticular disease, Bradycardia, Organophosphorus poisoning, Premedication in anesthesia, Poisoning or overdosage with compound having muscarinic actions, Ophthalmic Inflammatory eye disorders, Eye refraction.

Anticholinergics (antimuscarinics)/ Anti-spasmodics, Mydriatic and Cycloplegic agents

Atropine binds to and inhibit muscarinic acetylcholine receptors, producing a wide range of anticholinergic effects. Atropine is an anticholinergic agent which competitively blocks the muscarinic receptors in peripheral tissues such as the heart, intestines, bronchial muscles, iris and secretory glands. Some central stimulation may occur. Atropine abolishes bradycardia and reduces heart block due to vagal activity. Smooth muscles in the bronchi and gut are relaxed while glandular secretions are reduced. It also has mydriatic and cycloplegic effect.

Adult:

• IV: Bradycardia: 500 mcg every 3-5 mins. Total: 3 mg.
• IV/IM: Organophosphorus poisoning: 2 mg every 10-30 mins until muscarinic effects disappear or atropine toxicity appears.
• IM/SC: Premedication in anesthesia: 300-600 mcg 30-60 mins before anesthesia.
• IV/IM/SC: Poisoning or overdosage with compound having muscarinic actions: 0.6-1 mg, repeat 2 hrly.
• Ophthalmic: Inflammatory eye disorders: As 0.5-1% solution: 1-2 drops 4 times/day.
• Ophthalmic: refraction: 1% solution 1 drop twice daily for 1-2 days before procedure.
• Oral: Non ulcer dyspepsia, Irritable bowel syndrome, Diverticular disease: 0.6-1.2 mg as a single dose at bedtime.

Usual Pediatric Dose for Anesthesia:

• 7 to 16 pounds: 0.1 mg, IV, IM, or subcutaneously
• 17 to 24 pounds: 0.15 mg, IV, IM, or subcutaneously
• 24 to 40 pounds: 0.2 mg, IV, IM, or subcutaneously
• 40 to 65 pounds: 0.3 mg, IV, IM, or subcutaneously
• 65 to 90 pounds: 0.4 mg, IV, IM, or subcutaneously
• Over 90 pounds: 0.4 to 0.6 mg, IV, IM, or subcutaneously

Injection: Dry mouth, dysphagia, constipation, flushing and dryness of skin, tachycardia, palpitations, arrhythmias, mydriasis, photophobia, cycloplegia, raised intraocular pressure. Toxic doses cause tachycardia, hyperpyrexia, restlessness, confusion, excitement, hallucinations, delirium and may progress to circulatory failure and resp depression.

Eye drops or ointment: Systemic toxicity esp in children, on prolonged use may lead to irritation, hyperaemia, oedema and conjunctivitis. Increased intraocular pressure.

Glaucoma, chronic respiratory disease, sick sinus syndrome, thyrotoxicosis, cardiac failure, pyloric stenosis, prostatic hypertrophy.

Reflux oesophagitis; elderly; infants and children; Pregnancy.

Additive anticholinergic effects with quinidine, antidepressants and some antihistamines.

Pregnancy Category C. Animal reproduction studies have not been conducted with atropine. It also is not known whether atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. Atropine should be given to a pregnant woman only if clearly needed.

May cause hyperthermia, hypertension, increased respiratory rate, nausea and vomiting. May also lead to CNS stimulation. Severe intoxication may lead to CNS depression, coma, respiratory failure and death.

Store atropine at room temperature between 20 to 25° C. Store away from heat, moisture, and light. Keep atropine out of the reach of children.

Atropine is indicated for Non ulcer dyspepsia, Irritable bowel syndrome, Diverticular disease, Bradycardia, Organophosphorus poisoning, Premedication in anesthesia, Poisoning or overdosage with compound having muscarinic actions, Ophthalmic Inflammatory eye disorders, Eye refraction.

Anticholinergics (antimuscarinics)/ Anti-spasmodics, Mydriatic and Cycloplegic agents

Atropine binds to and inhibit muscarinic acetylcholine receptors, producing a wide range of anticholinergic effects. Atropine is an anticholinergic agent which competitively blocks the muscarinic receptors in peripheral tissues such as the heart, intestines, bronchial muscles, iris and secretory glands. Some central stimulation may occur. Atropine abolishes bradycardia and reduces heart block due to vagal activity. Smooth muscles in the bronchi and gut are relaxed while glandular secretions are reduced. It also has mydriatic and cycloplegic effect.

Adult:

• IV: Bradycardia: 500 mcg every 3-5 mins. Total: 3 mg.
• IV/IM: Organophosphorus poisoning: 2 mg every 10-30 mins until muscarinic effects disappear or atropine toxicity appears.
• IM/SC: Premedication in anesthesia: 300-600 mcg 30-60 mins before anesthesia.
• IV/IM/SC: Poisoning or overdosage with compound having muscarinic actions: 0.6-1 mg, repeat 2 hrly.
• Ophthalmic: Inflammatory eye disorders: As 0.5-1% solution: 1-2 drops 4 times/day.
• Ophthalmic: refraction: 1% solution 1 drop twice daily for 1-2 days before procedure.
• Oral: Non ulcer dyspepsia, Irritable bowel syndrome, Diverticular disease: 0.6-1.2 mg as a single dose at bedtime.

Usual Pediatric Dose for Anesthesia:

• 7 to 16 pounds: 0.1 mg, IV, IM, or subcutaneously
• 17 to 24 pounds: 0.15 mg, IV, IM, or subcutaneously
• 24 to 40 pounds: 0.2 mg, IV, IM, or subcutaneously
• 40 to 65 pounds: 0.3 mg, IV, IM, or subcutaneously
• 65 to 90 pounds: 0.4 mg, IV, IM, or subcutaneously
• Over 90 pounds: 0.4 to 0.6 mg, IV, IM, or subcutaneously

Injection: Dry mouth, dysphagia, constipation, flushing and dryness of skin, tachycardia, palpitations, arrhythmias, mydriasis, photophobia, cycloplegia, raised intraocular pressure. Toxic doses cause tachycardia, hyperpyrexia, restlessness, confusion, excitement, hallucinations, delirium and may progress to circulatory failure and resp depression.

Eye drops or ointment: Systemic toxicity esp in children, on prolonged use may lead to irritation, hyperaemia, oedema and conjunctivitis. Increased intraocular pressure.

Glaucoma, chronic respiratory disease, sick sinus syndrome, thyrotoxicosis, cardiac failure, pyloric stenosis, prostatic hypertrophy.

Reflux oesophagitis; elderly; infants and children; Pregnancy.

Additive anticholinergic effects with quinidine, antidepressants and some antihistamines.

Pregnancy Category C. Animal reproduction studies have not been conducted with atropine. It also is not known whether atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. Atropine should be given to a pregnant woman only if clearly needed.

May cause hyperthermia, hypertension, increased respiratory rate, nausea and vomiting. May also lead to CNS stimulation. Severe intoxication may lead to CNS depression, coma, respiratory failure and death.

Store atropine at room temperature between 20 to 25° C. Store away from heat, moisture, and light. Keep atropine out of the reach of children.

Vitamin B1, B6 & B12 is indicated for the treatment of vitamin B1, B6 & B12 deficiency syndrome. It is also indicated for the supportive treatment of neuritis & non-inflammatory diseases of the nerves, e.g.- Diabetic neuropathy, Peripheral neuralgin, Lumbago, Myalgia, Optic neuritis, Sciatica, Facial neuralgia, Intercostal neuralgia, Spinal pain.

Specific combined vitamin preparations

Vitamin B1 converts carbohydrates, fatty acids and amino acids into energy, promotes healthy nerves, improves mood, strengthens the heart. Vitamin B6 forms RBCs, helps cells to make proteins, manufactures neurotransmitters e.g. serotonin and releases stored forms of energy, helps to prevent CVS diseases and stroke, helps to lift depression and eases insomnia. Vitamin B12 is essential for cell replication and important for RBC production, prevents anemia, helps to prevent depression, reduces nerve pain, numbness, tingling and lowers the risk of heart diseases.

The vitamin ingredients are absorbed well in per oral reception. It is widely distributed to most tissues and appears in breast milk. Within the cell, thiamine is mostly present as diphosphate. Thiamine is not stored to any appreciable extent in the body and amounts in excess of the body’s requirements are excreted in the urine as unchanged thiamine or as metabolites. Pyridoxine, pyridoxal and pyridoxamine are readily absorbed from the GIT following oral administration and are converted to the active forms of pyridoxal phosphate an pyridoxamine phosphate. They are stored mainly in liver where there is oxidation to 4-pyridoxic acid and other inactive metabolites, which are excreted in urine. As the dose increases, proportionally greater amounts are excreted unchanged in the urine.

Tablet: 1-3 Tablets per day or as advised by the physician.

Injection:

• In severe (acute) cases: 1 injection daily until the acute symptoms subside or taken as advised by the physician.
• In mild cases: 1 injection 2-3 times per week. Ampoules are preferably injected intramuscularly.

Use in children: There is no information on the use of this drug in children.

Generally well tolerated but allergic reactions may be observed in few cases.

Vitamin B1, Vitamin B6 and Vitamin B12 is contraindicated in patients on levodopa therapy, and in patients with hypersensitivity to any of the ingredients of the preparation.

Cyanocobalamin should not be given in patients with subacute degeneration of the spinal cord. Cyanocobalamin is not suitable form of vitamin B12 for the treatment of optic neuropathies associated with raised plasma concentrations of cyanocobalamin.

No drug interaction has been reported yet.

Oral tablet form is recommended but due to the presence of benzyl alcohol, injection is not recommended during pregnancy & lactation.

No overdosage symptoms are to be expected in the recommended dosage. If there is known overdose then treatment is symptomatic & supportive.

Keep out of reach of children. Store in a cool (below 25°C temperature) and dry place, protected from light.

Vitamin B1, B6 & B12 is indicated for the treatment of vitamin B1, B6 & B12 deficiency syndrome. It is also indicated for the supportive treatment of neuritis & non-inflammatory diseases of the nerves, e.g.- Diabetic neuropathy, Peripheral neuralgin, Lumbago, Myalgia, Optic neuritis, Sciatica, Facial neuralgia, Intercostal neuralgia, Spinal pain.

Specific combined vitamin preparations

Vitamin B1 converts carbohydrates, fatty acids and amino acids into energy, promotes healthy nerves, improves mood, strengthens the heart. Vitamin B6 forms RBCs, helps cells to make proteins, manufactures neurotransmitters e.g. serotonin and releases stored forms of energy, helps to prevent CVS diseases and stroke, helps to lift depression and eases insomnia. Vitamin B12 is essential for cell replication and important for RBC production, prevents anemia, helps to prevent depression, reduces nerve pain, numbness, tingling and lowers the risk of heart diseases.

The vitamin ingredients are absorbed well in per oral reception. It is widely distributed to most tissues and appears in breast milk. Within the cell, thiamine is mostly present as diphosphate. Thiamine is not stored to any appreciable extent in the body and amounts in excess of the body’s requirements are excreted in the urine as unchanged thiamine or as metabolites. Pyridoxine, pyridoxal and pyridoxamine are readily absorbed from the GIT following oral administration and are converted to the active forms of pyridoxal phosphate an pyridoxamine phosphate. They are stored mainly in liver where there is oxidation to 4-pyridoxic acid and other inactive metabolites, which are excreted in urine. As the dose increases, proportionally greater amounts are excreted unchanged in the urine.

Tablet: 1-3 Tablets per day or as advised by the physician.

Injection:

• In severe (acute) cases: 1 injection daily until the acute symptoms subside or taken as advised by the physician.
• In mild cases: 1 injection 2-3 times per week. Ampoules are preferably injected intramuscularly.

Use in children: There is no information on the use of this drug in children.

Generally well tolerated but allergic reactions may be observed in few cases.

Vitamin B1, Vitamin B6 and Vitamin B12 is contraindicated in patients on levodopa therapy, and in patients with hypersensitivity to any of the ingredients of the preparation.

Cyanocobalamin should not be given in patients with subacute degeneration of the spinal cord. Cyanocobalamin is not suitable form of vitamin B12 for the treatment of optic neuropathies associated with raised plasma concentrations of cyanocobalamin.

No drug interaction has been reported yet.

Oral tablet form is recommended but due to the presence of benzyl alcohol, injection is not recommended during pregnancy & lactation.

No overdosage symptoms are to be expected in the recommended dosage. If there is known overdose then treatment is symptomatic & supportive.

Keep out of reach of children. Store in a cool (below 25°C temperature) and dry place, protected from light.

Mefenamic Acid is indicated for-

• Fever
• Toothache
• Headache
• Migraine
• Primary dysmenorrhoea
• Menorrhagia
• Mild to moderate pain in rheumatoid arthritis and osteoarthritis
• Traumatic pain
• Low-back pain
• Juvenile chronic arthritis in children etc.

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

Mefenamic acid contains Mefenamic Acid which is a nonsteroidal agent with demonstrated analgesic, anti-inflammatory and antipyretic activity due to its dual action on prostaglandins. It inhibits the enzymes of prostaglandin synthetase and also antagonizes the actions of prostaglandin at the receptor sites.

Adult:

• 500 mg dose should be given to adults upto three times (1.5 gm total) per day with meals. The dosage may be reduced to 1 tablet (250 mg) three times daily.
• In case of menorrhagia: 500 mg three times daily with meals and from the onset of menses and continued according to the judgement of the physician.

Children:

• 6 months to 1 year: 5 ml three times/day.
• 2-4 years: 10 ml three times/day.
• 5-8 years: 10 ml four times /day.
• 9-12 years: 15 ml four times/day.

Treatment should not be continued for more than 7 days except on the advice of a physician.

The most frequently reported adverse experiences occurring in approximately 1-10% of patients are gastrointestinal: abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, nausea, Gl ulcers, vomiting, dizziness, abnormal renal function, pruritus, rashes.

It is contraindicated in patients with known hypersensitivity to Mefenamic Acid. It should not be used in patients with peptic ulcer, inflammatory bowel diseases, hepatic or renal impairment. It is also contraindicated in patients, whom aspirin and/or other NSAID's have induced symptoms of bronchospasm, skin rashes etc.

It should be administered with caution in allergic diseases especially in asthma. The treatment should be withdrawn in diarrhoea, rashes, cholestatic jaundice, thrombocytopenia, haemolytic anaemia.

Aspirin: As other NSAIDs, concomitant administration of Mefenamic Acid and Aspirin is not generally recommended because of the potential of increased adverse effects.

Warfarin: Mefenamic Acid can inhibit platelet aggregation and may prolong the prothrombin time in patients on warfarin therapy

The safety of Mefenamic acid on reproductive capacity and pregnancy has not been established. Thus, mefenamic acid should be used in women of childbearing potential and during pregnancy only when the potential benefits are expected to outweigh the potential risks. Trace amounts of Mefenamic acid may be present in breast milk and transmitted to the nursing infant. Thus Mefenamic acid should not be taken by the nursing mother because of the effects of this class of drugs on the infant's cardiovascular system.

Keep away from light, store in a cool and dry place. Keep out of reach of children.

Prophylaxis of organ rejection in kidney transplant: Mycophenolic acid is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. It is indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.

Immunosuppressant

Mycophenolic acid delayed-release tablets are enteric coated formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid. It is an immunosuppressive agent. It is an uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH). Therefore, it inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation to DNA. Mycophenolic acid has cytostatic effects on lymphocytes. It has been shown to prevent the occurrence of acute rejection of kidney and heart allotransplantation. It also decreases antibody production.

Dosage in adult kidney transplant patients: The recommended dose of Mycophenolic acid is 720 mg administered twice daily (1440 mg total daily dose).

Dosage in pediatric kidney transplant patients: The recommended dose of Mycophenolic acid in conversion (at least 6 months post-transplant) pediatric patients age 5 years and older is 400 mg/m2 body surface area (BSA) administered twice daily (up to a maximum dose of 720 mg administered twice daily). Pediatric patients with a BSA of 1.19 to 1.58 m2 may be dosed either with three Mycophenolic acid 180 mg tablets, or one 180 mg tablet plus one 360 mg tablet twice daily (1080 mg daily dose). Patients with a BSA of >1.58 m2 may be dosed either with four Mycophenolic acid 180 mg tablets, or two Mycophenolic acid 360 mg tablets twice daily (1440 mg daily dose).

Mycophenolic acid tablets should be taken on an empty stomach, 1 hour before or 2 hours after food intake. Tablets should not be crushed, chewed, or cut prior to ingesting. The tablets should be swallowed whole in order to maintain the integrity of the enteric coating.

The most common adverse reactions (≥20%) associated with the administration of Mycophenolic acid are anemia, leukopenia, constipation, diarrhea, vomiting, dyspepsia, urinary tract infection, CMV infection, insomnia, and postoperative pain.

Mycophenolic acid delayed-release tablets and Mycophenolate mofetil tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.

Mycophenolic acid tablets are used with caution because it-

• Can cause embryofetal toxicity
• Can increase new or reactive viral infections
• Can cause blood dyscrasias including pure red cell aplasia
• Can cause serious GI tract complications (gastrointestinal bleeding, perforations and ulcers)
• May increase the risk of developing lymphomas and other malignancies, particularly of the skin
• Use of live vaccine should be avoided during treatment with Mycophenolic acid

Caution should be exercised with concomitant administration of Antacids, Azathioprine, Cyclosporin, Rifampin, Sevelamer, Cholestyramine, Acyclovir, Metronidazole, Hormonal contraceptives as these medicines may decrease Mycophenolic acid concentration.

Pregnancy Category D. Can cause fetal harm.

Lactation: Discontinue Mycophenolic acid or discontinue nursing while on treatment or within 6 weeks after stopping therapy. Take into consideration the importance of the drug to the mother.

No data are available with regard to overdose.

Store at 25° C and Keep out of reach of children.

Prophylaxis of organ rejection in kidney transplant: Mycophenolic acid is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. It is indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.

Immunosuppressant

Mycophenolic acid delayed-release tablets are enteric coated formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid. It is an immunosuppressive agent. It is an uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH). Therefore, it inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation to DNA. Mycophenolic acid has cytostatic effects on lymphocytes. It has been shown to prevent the occurrence of acute rejection of kidney and heart allotransplantation. It also decreases antibody production.

Dosage in adult kidney transplant patients: The recommended dose of Mycophenolic acid is 720 mg administered twice daily (1440 mg total daily dose).

Dosage in pediatric kidney transplant patients: The recommended dose of Mycophenolic acid in conversion (at least 6 months post-transplant) pediatric patients age 5 years and older is 400 mg/m2 body surface area (BSA) administered twice daily (up to a maximum dose of 720 mg administered twice daily). Pediatric patients with a BSA of 1.19 to 1.58 m2 may be dosed either with three Mycophenolic acid 180 mg tablets, or one 180 mg tablet plus one 360 mg tablet twice daily (1080 mg daily dose). Patients with a BSA of >1.58 m2 may be dosed either with four Mycophenolic acid 180 mg tablets, or two Mycophenolic acid 360 mg tablets twice daily (1440 mg daily dose).

Mycophenolic acid tablets should be taken on an empty stomach, 1 hour before or 2 hours after food intake. Tablets should not be crushed, chewed, or cut prior to ingesting. The tablets should be swallowed whole in order to maintain the integrity of the enteric coating.

The most common adverse reactions (≥20%) associated with the administration of Mycophenolic acid are anemia, leukopenia, constipation, diarrhea, vomiting, dyspepsia, urinary tract infection, CMV infection, insomnia, and postoperative pain.

Mycophenolic acid delayed-release tablets and Mycophenolate mofetil tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.

Mycophenolic acid tablets are used with caution because it-

• Can cause embryofetal toxicity
• Can increase new or reactive viral infections
• Can cause blood dyscrasias including pure red cell aplasia
• Can cause serious GI tract complications (gastrointestinal bleeding, perforations and ulcers)
• May increase the risk of developing lymphomas and other malignancies, particularly of the skin
• Use of live vaccine should be avoided during treatment with Mycophenolic acid

Caution should be exercised with concomitant administration of Antacids, Azathioprine, Cyclosporin, Rifampin, Sevelamer, Cholestyramine, Acyclovir, Metronidazole, Hormonal contraceptives as these medicines may decrease Mycophenolic acid concentration.

Pregnancy Category D. Can cause fetal harm.

Lactation: Discontinue Mycophenolic acid or discontinue nursing while on treatment or within 6 weeks after stopping therapy. Take into consideration the importance of the drug to the mother.

No data are available with regard to overdose.

Store at 25° C and Keep out of reach of children.

Tolfenamic acid is used specifically for relieving the pain of migraine headache and also recommended for use as an analgesic in post-operative pain and fever.

Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs), Other drugs for migraine

Tolfenamic acid (N-(2-methyl-3-chlorophenyl) anthranilic acid) belongs to the fenamate group and is a potent inhibitor of cyclooxygenase enzyme, thus it inhibits the synthesis of important inflammatory mediators such as thromboxane (TX) B2 and prostaglandin (PG) E2. Prostaglandins are responsible for causing swelling pain and inflammation associated with these conditions. It acts not only by inhibiting prostaglandin synthesis, but it also has direct antagonistic action on its receptors.

Pharmacokinetic properties: Absorption Readily absorbed from GI tract. Peak plasma concentration: 60-90 min. Bioavailability 85%. Distribution: Protein-binding: 99% Plasma half-life 2 hours. Metabolism: Metabolised in the liver. Tolfenamic acid undergoes enterohepatic circulation. Excretion: Excreted in urine (90%) and faces.

Adult:

• Acute migraine attacks: 200 mg when symptoms appear may be repeated once after 1-2 hour.
• Mild to moderate pain: 100-200 mg tid
• Renal impairment: Dose adjustments may be needed.
• Severe renal impairment: Avoid.

Children: A pediatric dosage regimen has not yet been established.

Tolfenamic acid should be taken with food. Take water during or immediately after meals.

Dysuria especially in males, diarrhoea, nausea epigastric pain, vomiting, dyspepsia, erythema, headache, tremor, euphoria, fatigue, pulmonary infiltration & haematuria. Potentially fatal: Blood dyscrasias and hepatitis.

Active peptic ulcer or bleeding in the gut. Severe heart, kidney or liver failure.

Precaution should be needed for patients with asthma bronchospasm, bleeding disorders, cardiovascular diseases, peptic ulceration, hypertension, liver infection, cardiac or renal function impairment and elderly. Increase water intake or dose reduction to reduce dysuria.

The rate of absorption of Tolfenamic acid increases with Metoclopramide and Magnesium hydroxide but decreases with Aluminium hydroxide. Risk of bleeding with anticoagulants and other NSAIDS increases when use with Tolfenamic acid. It decreases antihypertensive response to loop diuretics, B-blockers and ACE Inhibitors. Co-administration increases plasma concentration of Lithium Methotrexate and cardiac glycosides. It also increases the risk of nephrotoxicity with ACE inhibitors, Ciclosporin, Tacrolimus or diuretics

This medicine is not recommended for using during pregnancy unless considered essential by doctor Not to be given during the third trimester of pregnancy. NSAID's can appear in breast milk in very low concentrations NSAID's should, if possible, be avoided when breastfeeding.

Symptoms include headache, nausea, vomiting, epigastric pain. gastrointestinal bleeding, diarrhoea excitation, coma, drowsiness dizziness, tinnitus, fainting and convulsions. In cases of significant poisoning, acute renal failure and liver damage are possible. Patients should be treated symptomatically as required.

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