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Drugs used for Rheumatoid Arthritis

Tocilizumab binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and has been shown to inhibit IL-6-mediated signaling through these receptors. IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes and fibroblasts. IL-6 has been shown to be involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation. IL-6 is also produced by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes such as rheumatoid arthritis.

Rheumatoid Arthritis: Recommended Adult Intravenous Dosage: When used in combination with DMARDs or as monotherapy the recommended starting dose is 4 mg per kg every 4 weeks followed by an increase to 8 mg per kg every 4 weeks based on clinical response.

• Patients less than 100 kg weight: 162 mg administered subcutaneously every other week, followed by an increase to every week based on clinical response
• Patients at or above 100 kg weight: 162 mg administered subcutaneously every week.

Giant Cell Arteritis: Recommended Adult Subcutaneous Dosage: The recommended dose of tocilizumab for adult patients with GCA is 162 mg given once every week as a subcutaneous injection, in combination with a tapering course of glucocorticoids. A dose of 162 mg given once every other week as a subcutaneous injection, in combination with a tapering course of glucocorticoids, may be prescribed based on clinical considerations. tocilizumab can be used alone following discontinuation of glucocorticoids. tocilizumab subcutaneous formulation is not intended for intravenous administration.

Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): Recommended Adult Subcutaneous Dosage: The recommended dose of tocilizumab for adult patients with SSc-ILD is 162 mg given once every week as a subcutaneous injection.

Polyarticular Juvenile Idiopathic Arthritis
Recommended Intravenous PJIA Dosage Every 4 Weeks-

• Patients less than 30 kg weight: 10 mg per kg
• Patients at or above 30 kg weight: 8 mg per kg

Recommended Subcutaneous PJIA Dosage-

• Patients less than 30 kg weight: 162 mg once every three weeks
• Patients at or above 30 kg weight: 162 mg once every two weeks

Systemic Juvenile Idiopathic Arthritis
Recommended Intravenous SJIA Dosage Every 2 Weeks-

• Patients less than 30 kg weight: 12 mg per kg
• Patients at or above 30 kg weight: 8 mg per kg

Recommended Subcutaneous SJIA Dosage-

• Patients less than 30 kg weight 162 mg every two weeks
• Patients at or above 30 kg weight 162 mg every week

Cytokine Release Syndrome
Recommended Intravenous CRS Dosage-

• Patients less than 30 kg weight: 12 mg per kg
• Patients at or above 30 kg weight: 8 mg per kg

Alone or in combination with corticosteroids.

General Dosing Information:

• It is recommended that tocilizumab not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm3, platelet count below 100,000 per mm3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN).
• tocilizumab doses exceeding 800 mg per infusion are not recommended in RA or CRS patients.

Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions.

Hypersensitivity to tocilizumab or to any of the excipients.

Interactions with CYP450 Substrates: Cytochrome P450s in the liver are down-regulated by infection and inflammation stimuli including cytokines such as IL-6. Inhibition of IL-6 signaling in RA patients treated with tocilizumab may restore CYP450 activities to higher levels than those in the absence of tocilizumab leading to increased metabolism of drugs that are CYP450 substrates. In vitro studies showed that tocilizumab has the potential to affect expression of multiple CYP enzymes including CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6 and CYP3A4. Its effect on CYP2C8 or transporters is unknown. In vivo studies with omeprazole, metabolized by CYP2C19 and CYP3A4, and simvastatin, metabolized by CYP3A4, showed up to a 28% and 57% decrease in exposure one week following a single dose of tocilizumab, respectively. The effect of tocilizumab on CYP enzymes may be clinically relevant for CYP450 substrates with narrow therapeutic index, where the dose is individually adjusted. Upon initiation or discontinuation of tocilizumab, in patients being treated with these types of medicinal products, perform therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) and the individual dose of the medicinal product adjusted as needed. Exercise caution when coadministering tocilizumab with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, e.g., oral contraceptives, lovastatin, atorvastatin, etc. The effect of tocilizumab on CYP450 enzyme activity may persist for several weeks after stopping therapy

Based on animal data, may cause fetal harm. Discontinue drug or nursing taking into consideration importance of drug to mother.

There are limited data available on overdoses with tocilizumab. One case of accidental overdose was reported with intravenous tocilizumab in which a patient with multiple myeloma received a dose of 40 mg per kg. No adverse drug reactions were observed. No serious adverse drug reactions were observed in healthy volunteers who received single doses of up to 28 mg per kg, although all 5 patients at the highest dose of 28 mg per kg developed dose-limiting neutropenia. In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions. Patients who develop adverse reactions should receive appropriate symptomatic treatment.

Tocilizumab must be refrigerated at 2ºC to 8ºC. Do not freeze. Protect the vials, syringes, and autoinjectors from light by storage in the original package until time of use, and keep syringes and autoinjectors dry.

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.

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.

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.

Tolterodine Tartrate is indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency, and/or urge incontinence.

BPH/ Urinary retention/ Urinary incontinence

Tolterodine is a competitive, specific muscarinic receptor antagonist which exhibits a selectivity for the urinary bladder over salivary glands, which have been demonstrated in non clinical pharmacological in vivo studies. Tolterodine has a high specificity for muscarinic receptors. A major active metabolite (5-hydroxymethyl derivative) of tolterodine exhibits a pharmacological profile which is similar to that of the parent compound. In extensive metabolisers this metabolite contributes significantly to the therapeutic effect of tolterodine. The effect of treatment can be expected within 4 weeks.

The recommended dose for tolterodine is 2 mg twice daily. In case of troublesome side effects the dose may be reduced from 2 mg to 1 mg twice daily.

The recommended total daily dose of tolterodine is 2 mg (1 mg b.i.d.) for patients with impaired renal function, impaired liver function, or receiving concomitant medication with potent CYP3A inhibitors, such as macrolide antibiotics (e.g. erythromycin and clarithromycin) or azole antifungal agents (e.g. ketoconazole, itraconazole and miconazole). After six months the need for further treatment should be considered.

Tolterodine may cause mild to moderate antimuscarinic effects, like dryness of mouth, dyspepsia and/or reduced lacrimation.

Tolterodine is contraindicated in those patients with urinary retention, uncontrolled narrow angle glaucoma, known hypersensitivity to tolterodine or any other component of the drug.

Tolterodine should be used with caution in the following patients:

• at risk for urinary retention
• at risk for decreased gastrointestinal motility
• with impaired renal function
• with impaired hepatic function

Organic reasons for urge and frequency should be considered before treatment.

Pharmacokinetic interactions are possible with other drugs metabolised by or inhibiting cytochrome P450 2D6 (CYP2D6) or CYP3A4. Concomitant treatment with fluoxetine does not result in a clinically significant interaction.

Ketoconazole, a potent inhibitor of CYP3A, significantly increased plasma concentrations of tolterodine when coadministered to poor metabolisers (i.e. persons devoid of CYP2D6 metabolic pathway).

Clinical studies have shown no interactions with warfarin or combined oral contraceptives (ethinyloestradiol or levonorgestrel).

There are no studies in pregnant women. Therefore, tolterodine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use of tolterodine during lactation should be avoided since no data on excretion of the drug into breast milk in humans is available.

Pediatric use: Safety and effectiveness of tolterodine in children have not been established.

Geriatric use: No overall differences in safety were observed between the older and younger patients treated with Tolterodine.

Overdosage with Tolterodine Tartrate capsules can potentially result in severe central anticholinergic effects and should be treated accordingly. ECG monitoring is recommended in the event of overdosage.

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

Tolterodine Tartrate is indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency, and/or urge incontinence.

BPH/ Urinary retention/ Urinary incontinence

Tolterodine is a competitive, specific muscarinic receptor antagonist which exhibits a selectivity for the urinary bladder over salivary glands, which have been demonstrated in non clinical pharmacological in vivo studies. Tolterodine has a high specificity for muscarinic receptors. A major active metabolite (5-hydroxymethyl derivative) of tolterodine exhibits a pharmacological profile which is similar to that of the parent compound. In extensive metabolisers this metabolite contributes significantly to the therapeutic effect of tolterodine. The effect of treatment can be expected within 4 weeks.

The recommended dose for tolterodine is 2 mg twice daily. In case of troublesome side effects the dose may be reduced from 2 mg to 1 mg twice daily.

The recommended total daily dose of tolterodine is 2 mg (1 mg b.i.d.) for patients with impaired renal function, impaired liver function, or receiving concomitant medication with potent CYP3A inhibitors, such as macrolide antibiotics (e.g. erythromycin and clarithromycin) or azole antifungal agents (e.g. ketoconazole, itraconazole and miconazole). After six months the need for further treatment should be considered.

Tolterodine may cause mild to moderate antimuscarinic effects, like dryness of mouth, dyspepsia and/or reduced lacrimation.

Tolterodine is contraindicated in those patients with urinary retention, uncontrolled narrow angle glaucoma, known hypersensitivity to tolterodine or any other component of the drug.

Tolterodine should be used with caution in the following patients:

• at risk for urinary retention
• at risk for decreased gastrointestinal motility
• with impaired renal function
• with impaired hepatic function

Organic reasons for urge and frequency should be considered before treatment.

Pharmacokinetic interactions are possible with other drugs metabolised by or inhibiting cytochrome P450 2D6 (CYP2D6) or CYP3A4. Concomitant treatment with fluoxetine does not result in a clinically significant interaction.

Ketoconazole, a potent inhibitor of CYP3A, significantly increased plasma concentrations of tolterodine when coadministered to poor metabolisers (i.e. persons devoid of CYP2D6 metabolic pathway).

Clinical studies have shown no interactions with warfarin or combined oral contraceptives (ethinyloestradiol or levonorgestrel).

There are no studies in pregnant women. Therefore, tolterodine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use of tolterodine during lactation should be avoided since no data on excretion of the drug into breast milk in humans is available.

Pediatric use: Safety and effectiveness of tolterodine in children have not been established.

Geriatric use: No overall differences in safety were observed between the older and younger patients treated with Tolterodine.

Overdosage with Tolterodine Tartrate capsules can potentially result in severe central anticholinergic effects and should be treated accordingly. ECG monitoring is recommended in the event of overdosage.

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.

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.

Dextromethorphan is indicated in Chronic dry cough or unproductive cough; Acute dry cough which is interfering with normal function or sleep.

Cough suppressant

Dextromethorphan suppresses the cough reflex by a direct action on the cough center in the medulla of the brain. Dextromethorphan shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist and acts as a non-competitive channel blocker. It is one of the widely used antitussives, and is also used to study the involvement of glutamate receptors in neurotoxicity.

Adults and Children over 12 years: 15 to 30 mg three to four times per day. However, 60 mg doses up to four times per day have been used without increased side effects.
Children between 6 and 12 years: 5-15 mg up to four times per day.
Children between 2 and 6 years: 2.5-5 mg up to four times per day.

Adverse effects with Dextromethorphan are rare, but nausea and dizziness sometimes occur. The drug produces no analgesia or addiction and little or no CNS depression. Excitation, confusion and respiratory depression may occur after overdosage.

Hypersensitivity to Dextromethorphan or any other component.

Do not use Dextromethorphan to control a cough that is associated with smoking, asthma, or emphysema, or a cough that is productive (produces sputum or phlegm).

The following medicines should be taken carefully while concomitantly use with Dextromethorphan: Amiodarone, Fluoexetine, Quinidine, CNS depressants and Monoamine oxidase (MAO) inhibitors.

Pregnancy: Adequate and well-controlled studies in human have not been done. However, Dextromethorphan has not been reported to cause birth defects.

Lactation: It is not known whether dextromethorphan passes into breast milk. However, Dextromethorphan has not been reported to cause problems in nursing babies.

Symptoms: In mild overdose, tachycardia, hypertension, vomiting, mydriasis, diaphoresis, nystagmus, euphoria, loss of motor coordination, and giggling; in moderate intoxication, in addition to those listed above, hallucinations and a plodding ataxic gait; in severely intoxication, agitation or somnolence.

Management: treatment is symptomatic and supportive. Naloxone may be useful in reversing toxicity.

Store at 15-30° C

Torasemide is indicated for the management of edema of cardiac, renal and hepatic origin.The management of hypertension, as a sole therapeutic agent or in combination with other classes of antihypertensive agents.

Loop diuretics

Torasemide inhibits the Na⁺/K⁺/2CI^- carrier system (via interference of the chloride binding site) in the lumen of the thick ascending portion of the loop of Henle, resulting in a decrease in reabsorption of sodium and chloride. This results in an increase in the rate of delivery of tubular fluid and electrolytes to the distal sites of hydrogen and potassium ion secretion, while plasma volume contraction increases aldosterone production. The increased delivery and high aldosterone levels promote sodium reabsorption at the distal tubules, and By increasing the delivery of sodium to the distal renal tubule, torasemide indirectly increases potassium excretion via the sodium-potassium exchange mechanism. Torasemide's effects in other segments of the nephron have not been demonstrated. Thus torasemide increases the urinary excretion of sodium, chloride, and water, but it does not significantly alter glomerular filtration rate, renal plasma flow, or acid-base balance. Torasemide's effects as a antihypertensive are due to its diuretic actions. By reducing extracellular and plasma fluid volume, blood pressure is reduced temporarily, and cardiac output also decreases.

Congestive heart failure: The usual initial oral dose is 10 mg or 20 mg once daily. If the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than 200 mg have not been adequately studied.

Chronic renal failure: The usual initial oral dose is 20 mg once daily. lf the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than 200mg have not been adequately studied.

Hepatic cirrhosis: The usual initial oral dose is 5 mg or 10 mg once daily, administered together with an aldosterone antagonist or a potassium sparing diuretic. If the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than 40 mg have not been adequately studied. Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials.

Hypertension: The usual initial oral dose is 2.5-5 mg once daily. If the 5 mg dose does not provide adequate reduction of blood pressure within 4 to 6 weeks, the dose may be increased to 10 mg once daily. If the response to 10 mg is insufficient, an additional antihypertensive should be added to the treatment regimen.

Usually torasemide is well tolerated. However, a few side effects like dry mouth, dizziness, tiredness, skin rash, diarrhea, constipation, nausea, vomiting, orthostatic hypotention and muscle cramp may occur. All side effects usually are mild and transient.

Torasemide is contraindicated in patients with known hypersensitivity to torasemide and other sulfonyl ureas. It is also contraindicated in patients who are anuric.

Precautions should be taken while torasemide is administered in the conditions like diabetes, gout, hypotension and liver failure.

Increased risk of severe hypokalaemia with amphotercin B, corticosteroids, carbenoxolone, hypokalaemia-causing medications. Increased risk of lithium toxicity. Increased potential for ototoxicity and nephrotoxicity with nephrotoxic or ototoxic medications e.g. aminoglycosides. High dose salicylates may increase the risk of salicylate toxicity. Increased risk of toxicity with digoxin. Reduced diuretic effect with NSAIDs. Increased risk of hypotension with antihypertensives.

Pregnancy: Adequate and well controlled studies of torasemide have not been carried out in pregnant woman. Because animal reproduction studies are not always predictive of human response, torasemide can be used during pregnancy only if clearly needed.

Nursing Mother: lt is not known whether torasemide is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when torasemide is administered to a nursing mother.

Use in children: Safety and efficacy of torasemide in children have not been established.

There is no human experience of overdoses of torasemide, but the signs and symptoms of overdosage can be anticipated to be those of excessive pharmacological effect: dehydration, hypovolemia, hypotension and hypokalemia. Treatment of overdose should consist of fluid and electrolyte supplement.

Store Torasemide at room temperature less than 30° C and keep in cool and dry place, away from moisture and sunlight. Keep the medicine out of the reach of children.

Torasemide is indicated for the management of edema of cardiac, renal and hepatic origin.The management of hypertension, as a sole therapeutic agent or in combination with other classes of antihypertensive agents.

Loop diuretics

Torasemide inhibits the Na⁺/K⁺/2CI^- carrier system (via interference of the chloride binding site) in the lumen of the thick ascending portion of the loop of Henle, resulting in a decrease in reabsorption of sodium and chloride. This results in an increase in the rate of delivery of tubular fluid and electrolytes to the distal sites of hydrogen and potassium ion secretion, while plasma volume contraction increases aldosterone production. The increased delivery and high aldosterone levels promote sodium reabsorption at the distal tubules, and By increasing the delivery of sodium to the distal renal tubule, torasemide indirectly increases potassium excretion via the sodium-potassium exchange mechanism. Torasemide's effects in other segments of the nephron have not been demonstrated. Thus torasemide increases the urinary excretion of sodium, chloride, and water, but it does not significantly alter glomerular filtration rate, renal plasma flow, or acid-base balance. Torasemide's effects as a antihypertensive are due to its diuretic actions. By reducing extracellular and plasma fluid volume, blood pressure is reduced temporarily, and cardiac output also decreases.

Congestive heart failure: The usual initial oral dose is 10 mg or 20 mg once daily. If the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than 200 mg have not been adequately studied.

Chronic renal failure: The usual initial oral dose is 20 mg once daily. lf the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than 200mg have not been adequately studied.

Hepatic cirrhosis: The usual initial oral dose is 5 mg or 10 mg once daily, administered together with an aldosterone antagonist or a potassium sparing diuretic. If the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than 40 mg have not been adequately studied. Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials.

Hypertension: The usual initial oral dose is 2.5-5 mg once daily. If the 5 mg dose does not provide adequate reduction of blood pressure within 4 to 6 weeks, the dose may be increased to 10 mg once daily. If the response to 10 mg is insufficient, an additional antihypertensive should be added to the treatment regimen.

Usually torasemide is well tolerated. However, a few side effects like dry mouth, dizziness, tiredness, skin rash, diarrhea, constipation, nausea, vomiting, orthostatic hypotention and muscle cramp may occur. All side effects usually are mild and transient.

Torasemide is contraindicated in patients with known hypersensitivity to torasemide and other sulfonyl ureas. It is also contraindicated in patients who are anuric.

Precautions should be taken while torasemide is administered in the conditions like diabetes, gout, hypotension and liver failure.

Increased risk of severe hypokalaemia with amphotercin B, corticosteroids, carbenoxolone, hypokalaemia-causing medications. Increased risk of lithium toxicity. Increased potential for ototoxicity and nephrotoxicity with nephrotoxic or ototoxic medications e.g. aminoglycosides. High dose salicylates may increase the risk of salicylate toxicity. Increased risk of toxicity with digoxin. Reduced diuretic effect with NSAIDs. Increased risk of hypotension with antihypertensives.

Pregnancy: Adequate and well controlled studies of torasemide have not been carried out in pregnant woman. Because animal reproduction studies are not always predictive of human response, torasemide can be used during pregnancy only if clearly needed.

Nursing Mother: lt is not known whether torasemide is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when torasemide is administered to a nursing mother.

Use in children: Safety and efficacy of torasemide in children have not been established.

There is no human experience of overdoses of torasemide, but the signs and symptoms of overdosage can be anticipated to be those of excessive pharmacological effect: dehydration, hypovolemia, hypotension and hypokalemia. Treatment of overdose should consist of fluid and electrolyte supplement.

Store Torasemide at room temperature less than 30° C and keep in cool and dry place, away from moisture and sunlight. Keep the medicine out of the reach of children.

Ophthalmic antibacterial drugs

Like other aminoglycosides, the bactericidal activity of Tobramycin is taken up into sensitive bacterial cells by an active transport process. Within the cell Tobramycin bind to the 30s, and to some extent to the 50s subunits of the bacterial ribosome, inhibiting protein synthesis and generating errors in the transcription of the genetic code. The manner in which cell death is brought about is imperfectly understood, and other mechanisms may contribute, including effects on membrane permeability.

Ophthalmic ointment:

• In mild to moderate infection, apply a small amount 2-3 times daily into the conjunctival sac(s).
• In severe cases of infection, apply a small amount 3-4 times daily into the conjunctival sac(s) until improvement is obtained, then reduce the dose gradually.

Ophthalmic solution:

• In mild to moderate infections: Instill 1or 2 drops into the affected eye(s) every 4 hours.
• In severe infections: Instill 2 drops into the affected eye(s) every hour until improvement is observed.

Pediatric use: Safety and effectiveness in children below the age of 1 year have not been established.

The most frequent side effect of Tobramycin ophthalmic solution is localized ocular toxicity, conjunctival erythema, hypersensitivity including lid itching and swelling.

It is contraindicated in patients who are hypersensitive to Tobramycin or any of the ingredients of the preparation.

Minor sensitivity may occur to topically applied aminoglycosides in some patients. If a sensitivity reaction occurs, discontinue use. Prolonged use may result in overgrowth of nonsusceptible organisms and fungi.

Care should be exercised when tobramycin is given to patients receiving other drugs with neuromauscular blocking agents or ototoxic.

Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. This drug should only be used during pregnancy, if the potential benefits outweigh the possible risk to the fetus. Drug may excreted into human milk. A decision should be made whether to discontinue nursing or to taking the drug.

Sign and symptoms of overdose may be similar to side effects as described above.

Protect from light, store in cool (below 25°C) & dry place. Keep out of reach of children. Used within 4 weeks after first opening.

This sterile Eye Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.

Ophthalmic steroid - antibiotic combined preparations

Like other amino-glycosides, the bactericidal activity of Tobramycin is accomplished by specific inhibition of normal protein synthesis in susceptible bacteria, but at the present time, very little is known about this action. It is thought that inhibition of protein synthesis is due to an action on ribosome that causes bacterial misreading of messenger RNA. The action of Dexamethasone is to inhibit the phospholipase A2, the first step in prostaglandin synthesis. Also Dexamethasone inhibits the chemo-tactic infiltration of neutrophils into the site of inflammation. The result is that its anti-inflammatory activity is 25 times greater and its overall therapeutic effectiveness 8-10 times greater than that of hydrocortisone.

Insert 1 drop into the conjunctival sac 3-5 times per day. During the initial 24 to 48 hours, the dosage may be increased to 1 drop every 2 hours.

The most frequent side effects to topical ocular Tobramycin are localized ocular toxicity and hypersensitivity, including lid itching and swelling and conjuntival erythema. The reactions due to the steroid component are elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsule cataract formation.

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and other viral disease of the cornea and conjunctiva. Mycobacterial infections of the eye caused by, but not limited to, acid-fast bacilli such as Mycobacterium tuberculosis, Mycobacterium leprae, or Mycobacterium avium. Fungal diseases of ocular structures. Untreated purulent infection of the eye. Hypersensitivity to any component of the medication.

Shake the bottle well before use. To prevent contamination do not touch the tip of the bottle to affected eye, eyelid or any surface of of the affected eye. Keep the bottle tightly closed after use.

No specific interaction studies were performed with this combination eye drops. In case of concomitant therapy with other topical ophthalmic medicines, an interval of 10 minutes should be allowed between successive applications.

Safety for use during pregnancy and lactation in humans has not been established

Use in paediatric: Safety and effectiveness in paediatric patients below 2 years have not been established.

Overdose of this eye drops may be flushed from the eye(s) with lukewarm tap water.

Store at room temperature. Close the bottle immediately after use. Do not use for longer than one month after opening the bottle.

Tiemonium Methylsulphate is an antispasmodic drug that reduces muscles spasm of the intestine, biliary system, bladder and uterus. It is used in symptomatic treatment of pain related to functional disorders of the digestive tract and biliary system. It is also indicated for the treatment of spasm and pain in urological and gynaecological diseases.

Anticholinergics

Tiemonium Methylsulphate a competitive antagonist of Acetylcholine, Histamine and strengthens of calcium bond with membrane phospholipids and proteins. Thus inhibits intracellular contractile protein of visceral cell which causes inhibition of visceral spasm and pain.

Tablet/Syrup-

• Adult: usual dose is 2-6 tablets or 3-9 teaspoonfuls syrup daily in divided doses.
• Children: 3 ml/kg or 6 mg/kg body weight daily in divided doses.

Injection: 1 Tiemonium Methylsulphate Injection 3 times daily, through Intravenous route slowly or Intramuscular route.

Suppository: 20 mg Tiemonium Methylsulphate suppository two or three times daily, through rectal route.

Tiemonium Methylsulphate may have the risk of hypotension & tachycardia in certain individuals.

It should not be used in urethroprostatic disorder involving a risk of urine retension. It is contraindicated in patient with having risk of angle closure glaucoma.

Caution should be taken during treatment of patients with disorders of the prostate. Caution should also be taken in case of chronic bronchitis, coronary insufficiency, ambient hyperthermia, renal & hepatic insufficiency. The risks of visual disturbances can make it dangerous to drive or use machines.

Tiemonium methylsulphate tablet should not be used with other drugs without prior consult of a registered physician to avoid possible drug interaction.

The results of animal studies of Tiemonium Methylsulphate did not reveal any teratogenic effects; no deformities have been reported up till now with normal use. In absence of sufficient data, prudence should be the rule for nursing mothers although no problems have been reported with normal use.

Paediatric use: safety and effectiveness of Tiemonium methylsulphate in paediatric patients have not been established.

Geriatric use: Efficacy and safety were maintained with increasing age.

There is not available data regarding the overdose of Tiemonium methylsulphate tablet.

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

Ophthalmic antibacterial drugs

Like other aminoglycosides, the bactericidal activity of Tobramycin is taken up into sensitive bacterial cells by an active transport process. Within the cell Tobramycin bind to the 30s, and to some extent to the 50s subunits of the bacterial ribosome, inhibiting protein synthesis and generating errors in the transcription of the genetic code. The manner in which cell death is brought about is imperfectly understood, and other mechanisms may contribute, including effects on membrane permeability.

Ophthalmic ointment:

• In mild to moderate infection, apply a small amount 2-3 times daily into the conjunctival sac(s).
• In severe cases of infection, apply a small amount 3-4 times daily into the conjunctival sac(s) until improvement is obtained, then reduce the dose gradually.

Ophthalmic solution:

• In mild to moderate infections: Instill 1or 2 drops into the affected eye(s) every 4 hours.
• In severe infections: Instill 2 drops into the affected eye(s) every hour until improvement is observed.

Pediatric use: Safety and effectiveness in children below the age of 1 year have not been established.

The most frequent side effect of Tobramycin ophthalmic solution is localized ocular toxicity, conjunctival erythema, hypersensitivity including lid itching and swelling.

It is contraindicated in patients who are hypersensitive to Tobramycin or any of the ingredients of the preparation.

Minor sensitivity may occur to topically applied aminoglycosides in some patients. If a sensitivity reaction occurs, discontinue use. Prolonged use may result in overgrowth of nonsusceptible organisms and fungi.

Care should be exercised when tobramycin is given to patients receiving other drugs with neuromauscular blocking agents or ototoxic.

Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. This drug should only be used during pregnancy, if the potential benefits outweigh the possible risk to the fetus. Drug may excreted into human milk. A decision should be made whether to discontinue nursing or to taking the drug.

Sign and symptoms of overdose may be similar to side effects as described above.

Protect from light, store in cool (below 25°C) & dry place. Keep out of reach of children. Used within 4 weeks after first opening.

Ophthalmic antibacterial drugs

Like other aminoglycosides, the bactericidal activity of Tobramycin is taken up into sensitive bacterial cells by an active transport process. Within the cell Tobramycin bind to the 30s, and to some extent to the 50s subunits of the bacterial ribosome, inhibiting protein synthesis and generating errors in the transcription of the genetic code. The manner in which cell death is brought about is imperfectly understood, and other mechanisms may contribute, including effects on membrane permeability.

Ophthalmic ointment:

• In mild to moderate infection, apply a small amount 2-3 times daily into the conjunctival sac(s).
• In severe cases of infection, apply a small amount 3-4 times daily into the conjunctival sac(s) until improvement is obtained, then reduce the dose gradually.

Ophthalmic solution:

• In mild to moderate infections: Instill 1or 2 drops into the affected eye(s) every 4 hours.
• In severe infections: Instill 2 drops into the affected eye(s) every hour until improvement is observed.

Pediatric use: Safety and effectiveness in children below the age of 1 year have not been established.

The most frequent side effect of Tobramycin ophthalmic solution is localized ocular toxicity, conjunctival erythema, hypersensitivity including lid itching and swelling.

It is contraindicated in patients who are hypersensitive to Tobramycin or any of the ingredients of the preparation.

Minor sensitivity may occur to topically applied aminoglycosides in some patients. If a sensitivity reaction occurs, discontinue use. Prolonged use may result in overgrowth of nonsusceptible organisms and fungi.

Care should be exercised when tobramycin is given to patients receiving other drugs with neuromauscular blocking agents or ototoxic.

Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. This drug should only be used during pregnancy, if the potential benefits outweigh the possible risk to the fetus. Drug may excreted into human milk. A decision should be made whether to discontinue nursing or to taking the drug.

Sign and symptoms of overdose may be similar to side effects as described above.

Protect from light, store in cool (below 25°C) & dry place. Keep out of reach of children. Used within 4 weeks after first opening.

This sterile Eye Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.

Ophthalmic steroid - antibiotic combined preparations

Like other amino-glycosides, the bactericidal activity of Tobramycin is accomplished by specific inhibition of normal protein synthesis in susceptible bacteria, but at the present time, very little is known about this action. It is thought that inhibition of protein synthesis is due to an action on ribosome that causes bacterial misreading of messenger RNA. The action of Dexamethasone is to inhibit the phospholipase A2, the first step in prostaglandin synthesis. Also Dexamethasone inhibits the chemo-tactic infiltration of neutrophils into the site of inflammation. The result is that its anti-inflammatory activity is 25 times greater and its overall therapeutic effectiveness 8-10 times greater than that of hydrocortisone.

Insert 1 drop into the conjunctival sac 3-5 times per day. During the initial 24 to 48 hours, the dosage may be increased to 1 drop every 2 hours.

The most frequent side effects to topical ocular Tobramycin are localized ocular toxicity and hypersensitivity, including lid itching and swelling and conjuntival erythema. The reactions due to the steroid component are elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsule cataract formation.

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and other viral disease of the cornea and conjunctiva. Mycobacterial infections of the eye caused by, but not limited to, acid-fast bacilli such as Mycobacterium tuberculosis, Mycobacterium leprae, or Mycobacterium avium. Fungal diseases of ocular structures. Untreated purulent infection of the eye. Hypersensitivity to any component of the medication.

Shake the bottle well before use. To prevent contamination do not touch the tip of the bottle to affected eye, eyelid or any surface of of the affected eye. Keep the bottle tightly closed after use.

No specific interaction studies were performed with this combination eye drops. In case of concomitant therapy with other topical ophthalmic medicines, an interval of 10 minutes should be allowed between successive applications.

Safety for use during pregnancy and lactation in humans has not been established

Use in paediatric: Safety and effectiveness in paediatric patients below 2 years have not been established.

Overdose of this eye drops may be flushed from the eye(s) with lukewarm tap water.

Store at room temperature. Close the bottle immediately after use. Do not use for longer than one month after opening the bottle.

This sterile Eye Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.

Ophthalmic steroid - antibiotic combined preparations

Like other amino-glycosides, the bactericidal activity of Tobramycin is accomplished by specific inhibition of normal protein synthesis in susceptible bacteria, but at the present time, very little is known about this action. It is thought that inhibition of protein synthesis is due to an action on ribosome that causes bacterial misreading of messenger RNA. The action of Dexamethasone is to inhibit the phospholipase A2, the first step in prostaglandin synthesis. Also Dexamethasone inhibits the chemo-tactic infiltration of neutrophils into the site of inflammation. The result is that its anti-inflammatory activity is 25 times greater and its overall therapeutic effectiveness 8-10 times greater than that of hydrocortisone.

Insert 1 drop into the conjunctival sac 3-5 times per day. During the initial 24 to 48 hours, the dosage may be increased to 1 drop every 2 hours.

The most frequent side effects to topical ocular Tobramycin are localized ocular toxicity and hypersensitivity, including lid itching and swelling and conjuntival erythema. The reactions due to the steroid component are elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsule cataract formation.

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and other viral disease of the cornea and conjunctiva. Mycobacterial infections of the eye caused by, but not limited to, acid-fast bacilli such as Mycobacterium tuberculosis, Mycobacterium leprae, or Mycobacterium avium. Fungal diseases of ocular structures. Untreated purulent infection of the eye. Hypersensitivity to any component of the medication.

Shake the bottle well before use. To prevent contamination do not touch the tip of the bottle to affected eye, eyelid or any surface of of the affected eye. Keep the bottle tightly closed after use.

No specific interaction studies were performed with this combination eye drops. In case of concomitant therapy with other topical ophthalmic medicines, an interval of 10 minutes should be allowed between successive applications.

Safety for use during pregnancy and lactation in humans has not been established

Use in paediatric: Safety and effectiveness in paediatric patients below 2 years have not been established.

Overdose of this eye drops may be flushed from the eye(s) with lukewarm tap water.

Store at room temperature. Close the bottle immediately after use. Do not use for longer than one month after opening the bottle.

Herbal and Nutraceuticals

Qurs Mulayin is an effective herbal remedy in relieving constipation by stimulating peristaltic movements. Constipation means slow movement of faeces through the large intestine, it is often associated with large quantities of dry, hard faeces in the descending colon that accumulated because of the long time available for absorption of fluid. A sufferer may find it extremely painful or difficult in defaecation. Qurs Mulayin stimulates peristalsis, makes the stool soft for smooth laxation.

1-2 tablet(s) with lukewarm water once daily or as prescribed by the physician.

No significant side effect has been observed in therapeutic dosage.

There is no known contraindication.

Keep out of reach of the children.

Protect from light. Keep in cool & dry place. Shake well before use.

Vitamin-B preparations

Thiamine, in the form of thiamine pyrophosphate, is the coenzyme for decarboxylation of α-ketoglutaric acid. Thiamine deficiency affects the peripheral nervous system, the gastrointestinal tract, and the cardiovascular system. This vitamin is necessary for the optimal growth of infants and children. Thiamine is not stored in the body, and is regularly lost from tissues during short periods of deficiency. In order to maintain normal health, an adequate amount of thiamine is required every day. Deficiency of thiamine leads to fatigue, anorexia, gastrointestinal disturbance, tachycardia, irritability and neurological symptoms. Beriberi, a disease due to vitamin B1 deficiency, is common in alcoholics, in pregnant women receiving an inadequate diet, and in people with malabsorption syndrome, prolonged diarrhoea and hepatic disease.

Thiamine is well absorbed from the gastrointestinal tract and widely distributed throughout the body. Thiamine is rapidly absorbed from the upper small intestine. Thiamine is not stored in the body to any appreciable extent. Excess ingested thiamine appears in urine as intact thiamine or as pyrimidine, which arises from degradation of the thiamine molecule. The plasma half life of thiamine is 24 hours.

Prophylaxis: 3 to 10 mg daily.
Mild chronic deficiency: 10 to 25 mg daily.
Severe deficiency: 200 to 300 mg daily.

Vitamin B1 does not have adverse effects when given orally, but in a few fatal cases anaphylactic reactions have occurred after intravenous administration of large doses (400 mg) in sensitive patients, especially children, and in one case following an intramuscular dose of 125 mg. The risk of such reactions increases with repeated administration of the drug by parenteral route. Transient mild soreness may occur at the site of intramuscular administration

There is no absolute contraindication but the risk of anaphylaxis is increased by repeated parenteral administration. Mild allergic phenomena, such as sneezing or mild asthma are warning signs that further may give rise to anaphylactic shock. To avoid this possibility it is advisable to start a second course of injection with a dose considerably lower than that previously used. Because of the above, vitamin B1 injection should not be given intravenously except in the case of comatose patients. Once thiamine deficiency is corrected there is no need for parenteral administration or for the administration of amounts in excess of daily requirement.

No hazardous drug interactions have been reported. Vitamin B1 acts synergistically with other vitamins of the B-complex group and its potential for causing adverse effects is considerably reduced.

The drug may be given safely to neonates, children, pregnant and lactating women and elderly patients.

Thiamine injection should be protected from light and moisture.