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

Drugs used in Gout

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

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

Acute gouty arthritis:

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

For prophylaxis during intercritical periods:

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

For prophylaxis against attacks of gout in patients undergoing surgery:

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

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

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

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

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

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

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

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

Renal Cell Carcinoma: Cabozantinib is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

Hepatocellular Carcinoma: Cabozantinib is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Sorafenib.

Tyrosine Kinase Inhibitor

In vitro biochemical and/or cellular assays have shown that Cabozantinib inhibits the tyrosine kinase activity of MET, VEGFR-1, -2 and -3, AXL, RET, ROS1, TYRO3, MER, KIT, TRKB, FLT-3, and TIE-2. These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, drug resistance, and maintenance of the tumor microenvironment.

Absorption: Median time to peak cabozantinib concentrations (T_max) ranged from 3 to 4 hours post-dose. A 19% increase in the Cmax of Cabozantinib compared to a Cabozantinib capsule formulation was observed following a single 140 mg dose. A less than 10% difference in the AUC was observed between Cabozantinib and a Cabozantinib capsule formulation.

Distribution: The oral volume of distribution (Vz/F) of Cabozantinib is approximately 319 L. Cabozantinib is highly protein-bound in human plasma (≥99.7%).

Elimination: The predicted terminal half-life is approximately 99 hours and the clearance (CL/F) at steady state is estimated to be 2.2 L/hr.

Metabolism: Cabozantinib is a substrate of CYP3A4 in vitro.

Excretion: Approximately 81% of the total administered radioactivity was recovered within a 48-day collection period following a single dose of radiolabeled 14 C- Cabozantinib in healthy subjects. Approximately 54% was recovered in feces and 27% in urine. Unchanged Cabozantinib accounted for 43% of the total radioactivity in feces and was not detectable in urine following a 72-hour collection.

Recommended Dosage for Renal Cell Carcinoma: The recommended dosage of Cabozantinib is 60 mg once daily without food until the patient no longer experiences clinical benefit or experiences unacceptable toxicity.

Recommended Dosage for Hepatocellular Carcinoma: The recommended dosage of Cabozantinib is 60 mg once daily without food until disease progression or unacceptable toxicity. Or, as directed by the registered physicians.

• Stop treatment with Cabozantinib at least 28 days prior to scheduled surgery, including dental surgery.
• Do not substitute Cabozantinib tablets with Cabozantinib capsules.
• Do not administer Cabozantinib with food. Administer at least 1 hour before or at least 2 hours after eating.
• Swallow Cabozantinib tablets whole. Do not crush Cabozantinib tablets.
• Do not take a missed dose within 12 hours of the next dose.
• Modify the dose for certain patients with hepatic impairment and for patients taking drugs known to strongly induce or inhibit CYP450.

Pediatric Use: The safety and effectiveness of Cabozantinib in pediatric patients have not been established.

It is contraindicated in patients with known hypersensitivity to Cabozantinib or any other components of this product.

Hemorrhage: Severe and fatal hemorrhages occurred with Cabozantinib. Discontinue Cabozantinib for Grade 3 or 4 hemorrhage. Do not administer Cabozantinib to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.

Perforations and Fistulas: Fistulas, including fatal cases, occurred in 1% of Cabozantinib-treated patients. Gastrointestinal (GI) perforations, including fatal cases, occurred in 1% of Cabozantinib-treated patients. Monitor patients for signs and symptoms of fistulas and perforations, including abscess and sepsis. Discontinue Cabozantinib in patients who experience a fistula that cannot be appropriately managed or a GI perforation.

Thrombotic Events: Cabozantinib increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism occurred in 2% of Cabozantinib
-treated patients. Fatal thrombotic events occurred in Cabozantinib-treated patients. Discontinue Cabozantinib in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic events that require medical intervention.

Hypertension and Hypertensive Crisis: Cabozantinib can cause hypertension, including hypertensive crisis. Do not initiate Cabozantinib in patients with uncontrolled hypertension. Monitor blood pressure regularly during Cabozantinib treatment. Withhold Cabozantinib for hypertension that is not adequately controlled with medical management; when controlled, resume Cabozantinib at a reduced dose. Discontinue Cabozantinib for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Diarrhea: Diarrhea occurred in 63% of patients treated with Cabozantinib. Withhold Cabozantinib until improvement to Grade 1 and resume Cabozantinib at a reduced dose for intolerable Grade 2 diarrhea, Grade 3 diarrhea that cannot be managed with standard antidiarrheal treatments, or Grade 4 diarrhea.

Palmar-Plantar Erythrodysesthesia: Palmar-plantar erythrodysesthesia (PPE) occurred in 44% of patients treated with Cabozantinib. Withhold Cabozantinib until improvement to Grade 1 and resume Cabozantinib at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.

Proteinuria: Proteinuria was observed in 7% of patients receiving Cabozantinib. Monitor urine protein regularly during Cabozantinib treatment. Discontinue Cabozantinib in patients who develop nephrotic syndrome.

Osteonecrosis of the Jaw: Osteonecrosis of the jaw (ONJ) occurred in <1% of patients treated with Cabozantinib. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to initiation of Cabozantinib and periodically during Cabozantinib. Advise patients regarding good oral hygiene practices. Withhold Cabozantinib for at least 28 days prior to scheduled dental surgery or invasive dental procedures, if possible. Withhold Cabozantinib for development of ONJ until complete resolution.

Wound Complications: Wound complications have been reported with Cabozantinib. Stop Cabozantinib at least 28 days prior to scheduled surgery. Resume Cabozantinib after surgery based on clinical judgment of adequate wound healing. Withhold Cabozantinib in patients with dehiscence or wound healing complications requiring medical intervention.

Reversible Posterior Leukoencephalopathy Syndrome: Reversible Posterior Leukoencephalopathy Syndrome (RPLS), a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, can occur with Cabozantinib. Perform an evaluation for RPLS in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function. Discontinue Cabozantinib in patients who develop RPLS.

Embryo-Fetal Toxicity: Based on data from animal studies and its mechanism of action, Cabozantinib can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Cabozantinib and for 4 months after the last dose.

Strong CYP3A4 Inhibitors: Coadministration of a Cabozantinib capsule formulation with a strong CYP3A4 inhibitor increased the exposure of Cabozantinib, which may increase the risk of exposure-related adverse reactions. Avoid coadministration of Cabozantinib with strong CYP3A4 inhibitors. Reduce the dosage of Cabozantinib if coadministration with strong CYP3A4 inhibitors cannot be avoided. Avoid grapefruit or grapefruit juice which may also increase exposure of Cabozantinib.

Strong CYP3A Inducers: Coadministration of a Cabozantinib capsule formulation with a strong CYP3A4 inducer decreased the exposure of Cabozantinib, which may reduce efficacy. Avoid coadministration of Cabozantinib with strong CYP3A4 inducers. Increase the dosage of Cabozantinib if coadministration with strong CYP3A4 inducers cannot be avoided. Avoid St. John's Wort which may also decrease exposure of Cabozantinib.

Pregnancy: Cabozantinib can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk.

Lactation: There is no information regarding the presence of Cabozantinib or its metabolites in human milk, or their effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in breastfed children, women should be advised not to breastfeed during treatment with Cabozantinib and for 4 months after the final dose.

Contraception: Cabozantinib can cause fetal harm when administered to a pregnant woman.

Females: Females of reproductive potential should be advised to use effective contraception during treatment with Cabozantinib and for 4 months after the final dose.

Infertility: Females and Males: Based on findings in animals, Cabozantinib may impair fertility in females and males of reproductive potential.

One case of overdosage was reported following administration of another formulation of cabozantinib; a patient inadvertently took twice the intended dose for 9 days. The patient suffered Grade 3 memory impairment, Grade 3 mental status changes, Grade 3 cognitive disturbance, Grade 2 weight loss, and Grade 1 increase in BUN. The extent of recovery was not documented.

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

Renal Cell Carcinoma: Cabozantinib is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

Hepatocellular Carcinoma: Cabozantinib is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Sorafenib.

Tyrosine Kinase Inhibitor

In vitro biochemical and/or cellular assays have shown that Cabozantinib inhibits the tyrosine kinase activity of MET, VEGFR-1, -2 and -3, AXL, RET, ROS1, TYRO3, MER, KIT, TRKB, FLT-3, and TIE-2. These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, drug resistance, and maintenance of the tumor microenvironment.

Absorption: Median time to peak cabozantinib concentrations (T_max) ranged from 3 to 4 hours post-dose. A 19% increase in the Cmax of Cabozantinib compared to a Cabozantinib capsule formulation was observed following a single 140 mg dose. A less than 10% difference in the AUC was observed between Cabozantinib and a Cabozantinib capsule formulation.

Distribution: The oral volume of distribution (Vz/F) of Cabozantinib is approximately 319 L. Cabozantinib is highly protein-bound in human plasma (≥99.7%).

Elimination: The predicted terminal half-life is approximately 99 hours and the clearance (CL/F) at steady state is estimated to be 2.2 L/hr.

Metabolism: Cabozantinib is a substrate of CYP3A4 in vitro.

Excretion: Approximately 81% of the total administered radioactivity was recovered within a 48-day collection period following a single dose of radiolabeled 14 C- Cabozantinib in healthy subjects. Approximately 54% was recovered in feces and 27% in urine. Unchanged Cabozantinib accounted for 43% of the total radioactivity in feces and was not detectable in urine following a 72-hour collection.

Recommended Dosage for Renal Cell Carcinoma: The recommended dosage of Cabozantinib is 60 mg once daily without food until the patient no longer experiences clinical benefit or experiences unacceptable toxicity.

Recommended Dosage for Hepatocellular Carcinoma: The recommended dosage of Cabozantinib is 60 mg once daily without food until disease progression or unacceptable toxicity. Or, as directed by the registered physicians.

• Stop treatment with Cabozantinib at least 28 days prior to scheduled surgery, including dental surgery.
• Do not substitute Cabozantinib tablets with Cabozantinib capsules.
• Do not administer Cabozantinib with food. Administer at least 1 hour before or at least 2 hours after eating.
• Swallow Cabozantinib tablets whole. Do not crush Cabozantinib tablets.
• Do not take a missed dose within 12 hours of the next dose.
• Modify the dose for certain patients with hepatic impairment and for patients taking drugs known to strongly induce or inhibit CYP450.

Pediatric Use: The safety and effectiveness of Cabozantinib in pediatric patients have not been established.

It is contraindicated in patients with known hypersensitivity to Cabozantinib or any other components of this product.

Hemorrhage: Severe and fatal hemorrhages occurred with Cabozantinib. Discontinue Cabozantinib for Grade 3 or 4 hemorrhage. Do not administer Cabozantinib to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.

Perforations and Fistulas: Fistulas, including fatal cases, occurred in 1% of Cabozantinib-treated patients. Gastrointestinal (GI) perforations, including fatal cases, occurred in 1% of Cabozantinib-treated patients. Monitor patients for signs and symptoms of fistulas and perforations, including abscess and sepsis. Discontinue Cabozantinib in patients who experience a fistula that cannot be appropriately managed or a GI perforation.

Thrombotic Events: Cabozantinib increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism occurred in 2% of Cabozantinib
-treated patients. Fatal thrombotic events occurred in Cabozantinib-treated patients. Discontinue Cabozantinib in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic events that require medical intervention.

Hypertension and Hypertensive Crisis: Cabozantinib can cause hypertension, including hypertensive crisis. Do not initiate Cabozantinib in patients with uncontrolled hypertension. Monitor blood pressure regularly during Cabozantinib treatment. Withhold Cabozantinib for hypertension that is not adequately controlled with medical management; when controlled, resume Cabozantinib at a reduced dose. Discontinue Cabozantinib for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Diarrhea: Diarrhea occurred in 63% of patients treated with Cabozantinib. Withhold Cabozantinib until improvement to Grade 1 and resume Cabozantinib at a reduced dose for intolerable Grade 2 diarrhea, Grade 3 diarrhea that cannot be managed with standard antidiarrheal treatments, or Grade 4 diarrhea.

Palmar-Plantar Erythrodysesthesia: Palmar-plantar erythrodysesthesia (PPE) occurred in 44% of patients treated with Cabozantinib. Withhold Cabozantinib until improvement to Grade 1 and resume Cabozantinib at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.

Proteinuria: Proteinuria was observed in 7% of patients receiving Cabozantinib. Monitor urine protein regularly during Cabozantinib treatment. Discontinue Cabozantinib in patients who develop nephrotic syndrome.

Osteonecrosis of the Jaw: Osteonecrosis of the jaw (ONJ) occurred in <1% of patients treated with Cabozantinib. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to initiation of Cabozantinib and periodically during Cabozantinib. Advise patients regarding good oral hygiene practices. Withhold Cabozantinib for at least 28 days prior to scheduled dental surgery or invasive dental procedures, if possible. Withhold Cabozantinib for development of ONJ until complete resolution.

Wound Complications: Wound complications have been reported with Cabozantinib. Stop Cabozantinib at least 28 days prior to scheduled surgery. Resume Cabozantinib after surgery based on clinical judgment of adequate wound healing. Withhold Cabozantinib in patients with dehiscence or wound healing complications requiring medical intervention.

Reversible Posterior Leukoencephalopathy Syndrome: Reversible Posterior Leukoencephalopathy Syndrome (RPLS), a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, can occur with Cabozantinib. Perform an evaluation for RPLS in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function. Discontinue Cabozantinib in patients who develop RPLS.

Embryo-Fetal Toxicity: Based on data from animal studies and its mechanism of action, Cabozantinib can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Cabozantinib and for 4 months after the last dose.

Strong CYP3A4 Inhibitors: Coadministration of a Cabozantinib capsule formulation with a strong CYP3A4 inhibitor increased the exposure of Cabozantinib, which may increase the risk of exposure-related adverse reactions. Avoid coadministration of Cabozantinib with strong CYP3A4 inhibitors. Reduce the dosage of Cabozantinib if coadministration with strong CYP3A4 inhibitors cannot be avoided. Avoid grapefruit or grapefruit juice which may also increase exposure of Cabozantinib.

Strong CYP3A Inducers: Coadministration of a Cabozantinib capsule formulation with a strong CYP3A4 inducer decreased the exposure of Cabozantinib, which may reduce efficacy. Avoid coadministration of Cabozantinib with strong CYP3A4 inducers. Increase the dosage of Cabozantinib if coadministration with strong CYP3A4 inducers cannot be avoided. Avoid St. John's Wort which may also decrease exposure of Cabozantinib.

Pregnancy: Cabozantinib can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk.

Lactation: There is no information regarding the presence of Cabozantinib or its metabolites in human milk, or their effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in breastfed children, women should be advised not to breastfeed during treatment with Cabozantinib and for 4 months after the final dose.

Contraception: Cabozantinib can cause fetal harm when administered to a pregnant woman.

Females: Females of reproductive potential should be advised to use effective contraception during treatment with Cabozantinib and for 4 months after the final dose.

Infertility: Females and Males: Based on findings in animals, Cabozantinib may impair fertility in females and males of reproductive potential.

One case of overdosage was reported following administration of another formulation of cabozantinib; a patient inadvertently took twice the intended dose for 9 days. The patient suffered Grade 3 memory impairment, Grade 3 mental status changes, Grade 3 cognitive disturbance, Grade 2 weight loss, and Grade 1 increase in BUN. The extent of recovery was not documented.

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

This inhalation aerosol is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continues to have evidence of bronchospasm and who requires a second bronchodilator.

Combined bronchodilators

This inhalation aerosol is a combination of Salbutamol (as Sulphate) and Ipratropium Bromide. It is a hydrofluoroalkane (HFA) based environment friendly inhaler. Because it does not contain chlorofluorocarbon (CFC) as propellant which is one of the main reasons of ozone layer depletion.

Salbutamol is a short acting beta2-adrenergic bronchodilator and Ipratropium Bromide is an anticholinergic bronchodilator. When used in combination, Ipratropium Bromide prevents the increase in intracellular concentration of cyclic guanosine monophosphate, which are caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle. This inhalation aerosol is expected to maximize the response of the treatment in patients with chronic obstructive pulmonary disease (COPD) by reducing bronchospasm through two distinctly different mechanisms, anticholinergic (parasympatholytic) and sympathomimetic. Simultaneous administration of an anticholinergic (Ipratropium Bromide) and a beta 2-sympathomimetic (Salbutamol) is designed to benefit the patient by producing a greater bronchodilatory effect than when either drug is utilized alone at its recommended dosage.

Adult dose (Including the elderly): 2 puffs of Salpium 4 times a day (Patients may take additional puffs as required but a total number of puffs should not exceed 12 in 24 hours). Or as directed by the physician.

Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.

Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):

1. Take off the cap.
2. Shake the inhaler (at least six times) vigorously before each use.
3. If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
4. Breathe out as full as comfortably possible & hold the inhaler upright.
5. Place the actuator into mouth between the teeth and close lips around the mouthpiece.
6. While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
7. Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
8. If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
9. After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
10. Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.

Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

Due to presence of Salbutamol, mild tremor and headache have been reported. These usually disappear with continuous treatment. There have been very rare reports of treatments muscle cramp, hypersensitivity reactions including angioedema, urticaria, bronchospasm and hypotension.

For the presence of Ipratropium Bromide headache, influenza, chest pain, nausea, dyspnea, coughing, pharyngitis, sinusitis are rarely reported.

This inhalation aerosol is contraindicated in patients with a history of hypersensitivity to Soya-Lecithin or related food products such as soybean and peanut. This inhalation aerosol is also contraindicated in patients hypersensitive to any other components of the drug product or to atropine or its derivatives.

This inhalation aerosol has been used concomitantly with other drugs, including sympathomimetic bronchodilators, methylxanthines and steroids, commonly used in the treatment of COPD. No formal drug interaction studies have been performed with this inhalation aerosol and these or other medications commonly used in the treatment of COPD. Ipratropium Bromide should be co-administered cautiously with other anticholinergic agents and sympathomimetic agents, which may increase the risk of adverse cardiovascular effects. Beta-2-agonist containing drugs, like this inhalation aerosol, should be administrated with extreme caution in patients with non-potassium sparing diuretics, monoamine oxidase inhibitors or tricyclic antidepressants.

Ipratropium Bromide: Pregnancy category B. Studies have demonstrated no teratogenic effects as a result of ipratropium.

Salbutamol: Pregnancy category C. Salbutamol has been shown to be teratogenic in animals.

There are, however no adequate and well-controlled studies of Salpium Inhalation Aerosol (Salbutamol and Ipratropium Bromide combination) in pregnant woman. This inhalation aerosol should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known whether the components of the Salpium InhalationAerosol are excreted in human milk. As many drugs are excreted in human milk, Salpium should be cautiously administered to a nursing mother.

This inhalation aerosol contains Ipratropium Bromide and, therefore, should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction. Preparations containing sympathomimetic amines such as Salbutamol Sulphate should be used with caution in patients with convulsive disorders, hyperthyroidism, diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines.

The effects of overdosage are expected to be related primarily to Salbutamol Sulphate. Manifestations of overdosage with Salbutamol may include anginal pain, hypertension, hypokalemia and tachycardia.

Do not puncture, break or incinerate the pressurized canister even when apparently empty. Avoid storage in direct sunlight or heat. Store in a cool and dry place. Keep away from children. Keep away from eyes.

Salbutamol sulfate & Ipratropium bromide solution for inhalation is indicated for the treatment of reversible bronchospasm associated with obstructive airway diseases in patients who require more than a single bronchodilator.

Combined bronchodilators

Ipratropium Bromide is quickly absorbed after inhalation. The systemic bioavailability following inhalation is estimated to be less than 10% of the dose. Renal excretion of Ipratropium Bromide is given as 46% of the dose after intravenous administration. The half-life of the terminal elimination phase is about 1.6 hours as determined after intravenous administration. Elimination half-life of drug and metabolites is 3.6 hours as determined after radio labelling. Ipratropium Bromide does not penetrate the blood brain barrier.

Salbutamoi Sulphate is rapidly and completely absorbed following administration either by inhaled or oral route. Peak plasma Salbutamoi concentrations are seen within three hours of administration and it is excreted unchanged in the urine after 24 hours. The elimination half-life is 4 hours. Salbutamoi will cross the blood brain barrier reaching concentrations amounting to about five percent of the plasma concentrations.

It has been shown that co-nebulisation of Ipratropium Bromide and Salbutamoi Sulphate does not potentiate the systemic absorption of either component and that therefore the additive activity of this solution is due to the combined local effect on the lung following inhalation.

Salbutamol sulfate & Ipratropium bromide solution for inhalation in ampoule may be administered from a suitable nebulizer or an intermittent positive pressure ventilator.

• Adults (including elderly): Use one 3 ml ampoule in the nebulizer four times a day. Two additional treatments may be used per day, if needed.
• Children: Use and dose must be determined by doctor.

Patients should be advised to consult a doctor or the nearest hospital immediately in the case of acute or rapidly worsening dyspnoea if additional inhalations do not produce an adequate improvement.

Step 1: Twist off the top of the ampoule. Be careful to hold the ampoule upright.
Step 2: Squeeze the desired amount of the nebulizer solution into the nebulizer chamber.
Step 3: If dilution is needed follow the physician’s direction.

In common with other beta-agonists containing products, side effects of this solution can include fine tremor of skeletal muscles and nervousness and less frequently tachycardia, dizziness, palpitations or headache, especially in hypersensitive patients.

Potentially serious hypokalaemia may result from prolonged and/or high dose beta2 agonist therapy.

As with use of other inhalation therapy, cough, local irritation and less commonly inhalation induced bronchospasm can occur. As with other beta-mimetics, nausea, vomiting, sweating, weakness and myalgia/muscle cramps may occur. In rare cases decrease in diastolic blood pressure, increase in systolic blood pressure, arrhythmias, particularly after higher doses, may occur.

In individual cases psychological alterations have been reported under inhalation therapy with beta-mimetics.

The most frequent non-respiratory anticholinergic related adverse events are dryness of mouth and dysphonia. There have been isolated reports of ocular complications (i.e. mydriasis, increased intraocular pressure, angle closure glaucoma, and eye pain) when aerosolised ipratropium bromide either alone or in combination with adrenergic beta2 agonist, has escaped into the eyes. Ocular side effects, gastrointestinal motility disturbances and urinary retention may occur in rare cases and are reversible.

This is contraindicated in patients with hypertrophic obstructive tachyarrhythmia and in patients with a history of hypersensitivity to atropine or its derivatives, or to any other component of the product.

In the case of acute, rapidly worsening dyspnoea a doctor should be consulted immediately. Immediate hypersensitivity reactions may occur after administration of this solution as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal oedema.

The concurrent administration of other beta-mimetics, systemically absorbed anticholinergics and xanthine derivatives may increase the side effects.

Beta-agonist induced hypokalaemia may be increased by concomitant treatment with xanthine derivatives, glucocorticosteroids and diuretics. This should be taken into account particularly in patients with severe airway obstruction.

Hypokalaemia may result in an increased susceptibility to arrhythmias in patients receiving digoxin. It is recommended that serum potassium levels be monitored in such situations.

A potentially serious reduction in bronchodilator effect may occur during concurrent administration of beta-blockers.

Beta-adrenergic agonists should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of beta adrenergic agonists may be enhanced.

Inhalation of halogenated hydrocarbon anaesthetics such as halothane, trichloroethylene and enflurane may increase the susceptibility to the cardiovascular effects of beta-agonists.

Pregnancy category C. Animal studies with Salbutamoi Sulphate have demonstrated a teratogenic effect. It is not known whether this medication is harmful to the fetus. No evidence of abnormalities has been reported in women receiving albuterol during pregnancy. This solution should be used during pregnancy only if the potential benefit justifies. This solution should be used with caution before childbirth in view of Salbutamol's inhibitory effects on uterine contractions.

Salbutamol Sulphate and Ipratropium Bromide are probably excreted in breast milk and their effects on neonates are not known. Although lipid-insoluble quaternary bases pass into breast milk, it is unlikely that this will happen to any extent especially when taken by inhalation. However, because many drugs are excreted in breast milk, caution should be exercised when This solution is administered to a nursing woman.

The effects of overdosage are expected to be primarily related to Salbutamol because acute overdosage with Ipratropium Bromide is unlikely as it is not well absorbed systemically after inhalation or oral administration.

Symptoms: Manifestations of overdosage with salbutamol may include tachycardia, anginal pain, hypertension, hypotension , palpitations, tremor, widening of the pulse pressure, arrhythmia and flushing.

Therapy: Administration of sedatives, tranquillisers; in severe cases, intensive therapy. Beta-receptor blockers, preferably beta1-selective, are suitable as specific antidotes; however, a possible increase in bronchial obstruction must be taken into account and the dose should be adjusted carefully in patients suffering from bronchial asthma.

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

This eye drop is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.

Drugs for miotics and glaucoma

This eye drops is comprised of two components: Brimonidine Tartrate & Timolol Maleate. Brimonidine Tartrate is a selective alpha-2 adrenergic receptor agonist having a dual mechanism of action. It decreases aqueous humor production and increases nonpressure dependent uveoscleral outflow. Timolol Maleate is a β-adrenergic receptor antagonist that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity. It lowers IOP by reducing aqueous humor production. Therefore the combination of both drugs gives a rapid onset of action, with peak ocular hypotensive effect seen within two hours of administration.

Instill 1 drop in the affected eye(s) twice daily.

The most common side effects are allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperaemia, eye pruritus and ocular burning or stinging.

Contraindicated in patients with hypersensitivity to any component of this product. Also contraindicated in bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third-degree atrioventricular block, overt cardiac failure and cardiogenic shock.

Like other topically applied ophthalmic agents, it may be absorbed systemically. Due to the presence of Timolol, the same types of cardiovascular and pulmonary adverse reactions as seen with systemic beta-blockers may occur. Cautions should be exercised in treating patients with severe or unstable and uncontrolled cardiovascular or pulmonary diseases.

Specific drug interaction studies have not been conducted.

There are no adequate and well-controlled studies in pregnant women. Combipres should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Timolol has been detected in human milk but it is not known whether Brimonidine Tartrate is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue taking into account the importance of the drug to the mother.

Use in children: Safety and effectiveness in children below the age of 2 years have not been established.

Use in elderly patients: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Store at a cool & dry place, protect from light. Do not use longer than 30 days after the first opening of the bottle. Keep out of the reach of children.

This is indicated in-

• Patients with essential hypertension
• Patients with angina pectoris & hypertension as co-existing diseases
• ln post Ml patients
• ln patients with refractory angina pectoris where nitrate therapy has failed.

Combined antihypertensive preparations

This is a fixed-dose combination of Amlodipine and Atenolol. Amlodipine is a dihydropyridine calcium antagonist that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle; it has a greater effect on vascular smooth muscle than on cardiac muscle. Amlodipine is a peripheral vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. Amlodipine reduces tone, decreases coronary vasoreactivity and lowers cardiac demand by reducing afterload.

Atenolol is a cardioselective beta-blocker. The cardio-selectivity is dose-related. Atenolol causes a reduction in blood pressure by lowering cardiac output, decreasing the plasma renin activity and sympathetic outflow from CNS. Atenolol also causes a reduction in myocardial oxygen demand by virtue of its negative inotropic and negative chronotropic effects.

The recommended dosage is Amlodipine and Atenolol 5/25 mg tablet once daily. If necessary, the dosage may be increased to 5/25 mg two tablets daily or as advised by the physicians. The dosage however should be individualized.

The combination of Amlodipine and Atenolol is well tolerated. Overall side-effects include
fatigue, headache, edema, nausea, drowsiness, anxiety and depression.

Hypersensitivity to either component, sinus bradycardia, second and higher degrees of heart block, cardiogenic shock, hypotension, congestive heart failure, poor left ventricular function.

Bronchospasm: The combination should be used with caution in patients with airway obstruction.

Renal impairment: The combination can be used in patients with renal impairment. However, caution may be necessary if the creatinine clearance is less than 30 ml/min because of possible reduction in the excretion of unchanged Atenolol.

Hepatic impairment: Caution may be necessary in the use of the combination in patients with severe liver damage because of prolongation of the elimination half-life of Amlodipine.

Drug withdrawal: Since coronary heart disease may exist without being recognized, patients should be warned against stopping the drug suddenly. Any discontinuation should be gradual and under observation.

Disopyramide: Atenolol reduces the clearance of disopyramide by 20%. Additive negative inotropic effects on the heart may be produced.

Ampicillin: at doses of 1 gm and above may reduce Atenolol levels.

Oral antidiabetics and insulin: Beta-blockers may decrease tissue sensitivity to insulin and inhibit insulin secretion e.g. in response to oral antidiabetics. Atenolol has less potential for these actions.

The combination should be used during pregnancy only if the expected benefit outweighs the potential fetal risk. The combination should not be used by nursing mothers. If its use is considered necessary, breast-feeding should be stopped.

Though not documented, hypotension and less frequently congestive cardiac failure may occur in cases of overdosage. Unabsorbed drugs may be removed by gastric lavage or administration of activated charcoal. Symptomatic treatment is suggested.

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

This cream is indicated in the treatment of-

• Mixed and complicated Fungal, Protozoal & Bacterial infections,
• Mild to moderate vaginitis,
• Candidiasis and trichomoniasis,
• Pruritus vulvae,
• Dermatitis,
• Eczema,
• Genito-urinary infections.

Clobetasol / Clobetasone & Combined Preparations

This cream is a combination cream which exhibits anti-bacterial, anti-fungal, anti-protozoal & anti-inflammatory actions. Ofloxacin is a broad-spectrum antibiotic that acts against many gram-positive & gram-negative bacteria. Ornidazole belongs to the nitroimidazole group of antibiotics and is used to treat amoeba and trichomonas infections. Terbinafine is an Allylamine antifungal that inhibits biosynthesis of Ergosterol (an essential components if fungal cell membrane) via inhibition of Squalene Epoxidase enzyme causing fungal cell death. Clobetasol is a potent corticosteroid which exhibits anti-inflammatory, anti-pruritic and vasoconstrictive properties.

Apply by gently rubbing onto the affected area twice daily.

Burning, itching, irritation, dry skin

Contraindicated in patients hypersensitive to any of the components of the formulation.

Do not shallow. For external use only

No hazardous interactions have been reported.

The safe use of this preparation during pregnancy & lactation has not been established.

Store below 30°C. keep away from light and out of the reach of children. Do not freeze.

This Cream is indicated for the treatment of corticosteroid-responsive dermatoses when complicated by infections caused by bacteria and fungi. This is also effective in the treatment of tinea pedis, tinea cruris & tinea corporis, acute and chronic eczema.

Betamethasone & Combined preparations

This Cream combines the anti-inflammatory, antipruritic and vasoconstrictive actions of Betamethasone Dipropionate with the broad spectrum antifungal activity of Clotrimazole and the wide-spectrum bactericidal antibiotic activity of Gentamicin Sulfate. Clotrimazole appears to act on the fungal cell membrane, causing leakage of cell contents. Gentamicin provides highly effective topical treatment in primary and secondary bacterial infections of the skin.

Apply gently into the affected skin areas twice daily. Duration of therapy varies depending upon the extent and location of disease and patient response. For effective treatment, This Cream should be applied regularly.

Adverse reactions have been reported very rarely and include hypochromia, burning, erythema, exudation etc.

This Cream is contraindicated in those patients with a history of sensitivity reactions to any of its components.

Do not combine with any other product containing corticosteroid. Not for application to the face, avoid contact with eyes. Not for prolonged use or use in extensive areas, under an occlusive dressing, open wound, injured areas, exterior genital areas and skin folds.

Concomitant use with nephrotoxic drugs including other aminoglycosides, vancomycin and some of cephalosporins; or ototoxic drugs such as ethacrynic acid and furosemide may increase the risk of toxicity.

Since safety of topical corticosteroid in pregnant women has not been established, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

A decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the lactating mother.

This eye drop is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.

Drugs for miotics and glaucoma

This eye drops is comprised of two components: Brimonidine Tartrate & Timolol Maleate. Brimonidine Tartrate is a selective alpha-2 adrenergic receptor agonist having a dual mechanism of action. It decreases aqueous humor production and increases nonpressure dependent uveoscleral outflow. Timolol Maleate is a β-adrenergic receptor antagonist that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity. It lowers IOP by reducing aqueous humor production. Therefore the combination of both drugs gives a rapid onset of action, with peak ocular hypotensive effect seen within two hours of administration.

Instill 1 drop in the affected eye(s) twice daily.

The most common side effects are allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperaemia, eye pruritus and ocular burning or stinging.

Contraindicated in patients with hypersensitivity to any component of this product. Also contraindicated in bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third-degree atrioventricular block, overt cardiac failure and cardiogenic shock.

Like other topically applied ophthalmic agents, it may be absorbed systemically. Due to the presence of Timolol, the same types of cardiovascular and pulmonary adverse reactions as seen with systemic beta-blockers may occur. Cautions should be exercised in treating patients with severe or unstable and uncontrolled cardiovascular or pulmonary diseases.

Specific drug interaction studies have not been conducted.

There are no adequate and well-controlled studies in pregnant women. Combipres should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Timolol has been detected in human milk but it is not known whether Brimonidine Tartrate is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue taking into account the importance of the drug to the mother.

Use in children: Safety and effectiveness in children below the age of 2 years have not been established.

Use in elderly patients: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Store at a cool & dry place, protect from light. Do not use longer than 30 days after the first opening of the bottle. Keep out of the reach of children.

It is indicated for the treatment or prevention of any infection caused by Penicillin sensitive bacteria where a long acting Penicillin is required. It is indicated in-

• Gonorrhoea caused by Penicillin sensitive microorganisns
• Prevention of endocarditis during dental procedures
• Gas-gangrene following amputation

Benzylpenicillin & Phenoxymethyl penicillin

Benzylpenicillin has a bactericidal action against gram-positive bacteria, gram-­negative cocci, some other gram-negative bacteria, spirochetes and actinomycetes. It inhibits final cross-linking stage of peptidoglycan production through binding and inactivation of transpeptidases on the inner surface of the bacterial cell membrane thus inhibiting bacterial cell wall synthesis. It is inhibited by penicillinase and other lactamases.

Interferes with cell wall mucopeptide synthesis during active multiplication, resulting in bactericidal activity against susceptible microorganisms.

Add 3 ml of water for injection and shake vigorously.

Adults: 4,00,000 units once daily or twice daily.
Children: Over 25 kg as for adults; under 25 kg reduce proportionally. In severe cases dose may be doubled.

Intramuscular injection is the only route of administration of Procaine Penicillin.

This should be injected IM into the buttocks, thigh, deltoid or triceps muscle. In case continuous injection is necessitated, the injection site should be changed every time.

Allergic reactions may occur but usually resolve on cessation of therapy.

Hypersensitivity to penicillin.

Hypersensitivity to cephalosporins. Renal impairment. CHF. Infant. Elderly.

Potentially hazardous interactions: invitro Penicillin inactivates Amino- glycosides, so that they should not be mixed in infusion fluids.

Pregnancy Category B. Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect that was not confirmed in controlled studies in women in the 1st trimester.

Add about 8 ml of sterile water for injection to the vial and shake vigorously to make a homogenous suspended solution.

Store at room temperature.

Anti-platelet drugs

Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen at 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.

Aspirin inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thus inhibiting the generation of thromboxane A2 a powerful inducer of platelet aggregation and vasoconstriction.

The recommended oral dose is one tablet daily.

This combination is generally well tolerated.

This combination is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

Oral anticoagulants, NSAIDs, Metamizole, SSRIs, CYP2C19 inhibitors increase the risk of bleeding. It shows interaction with Tonofovir, Valproic acid, Varicella vaccine, Acetazolamide and Nicorandil.

There are no adequate and well-controlled studies in pregnant women. It should be used during first and second trimesters of pregnancy only if clearly needed. It is contraindicated during the third trimester of pregnancy. It is unknown whether Clopidogrel is excreted in human breast milk but Aspirin is known to be excreted in human milk. This Drug should be discontinued during the breast feeding.

It should not be given to children, particularly those under 12 years, unless the expected benefits outweight the possible risks. Aspirin may be a contributory factor in the causation of Reye’s syndrome in some children.

Clopidogrel overdose may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability. In moderate aspirin intoxication dizziness, headache, tinnitus, confusion, and gastrointestinal symptoms may occur which can be treated by inducing vomiting followed by gastric lavage if needed. In severe Aspirin intoxication respiratory alkalosis respiratory acidosis, metabolic acidosis, hyperthermia, perspiration, dehydration can occur. It can be treated with haemodialysis and other symptomatic treatment.

Keep in a cool & dry place (below 30o C), protected from light & moisture. Keep out of the reach of children.

This eye drop is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.

Drugs for miotics and glaucoma

This eye drops is comprised of two components: Brimonidine Tartrate & Timolol Maleate. Brimonidine Tartrate is a selective alpha-2 adrenergic receptor agonist having a dual mechanism of action. It decreases aqueous humor production and increases nonpressure dependent uveoscleral outflow. Timolol Maleate is a β-adrenergic receptor antagonist that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity. It lowers IOP by reducing aqueous humor production. Therefore the combination of both drugs gives a rapid onset of action, with peak ocular hypotensive effect seen within two hours of administration.

Instill 1 drop in the affected eye(s) twice daily.

The most common side effects are allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperaemia, eye pruritus and ocular burning or stinging.

Contraindicated in patients with hypersensitivity to any component of this product. Also contraindicated in bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third-degree atrioventricular block, overt cardiac failure and cardiogenic shock.

Like other topically applied ophthalmic agents, it may be absorbed systemically. Due to the presence of Timolol, the same types of cardiovascular and pulmonary adverse reactions as seen with systemic beta-blockers may occur. Cautions should be exercised in treating patients with severe or unstable and uncontrolled cardiovascular or pulmonary diseases.

Specific drug interaction studies have not been conducted.

There are no adequate and well-controlled studies in pregnant women. Combipres should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Timolol has been detected in human milk but it is not known whether Brimonidine Tartrate is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue taking into account the importance of the drug to the mother.

Use in children: Safety and effectiveness in children below the age of 2 years have not been established.

Use in elderly patients: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Store at a cool & dry place, protect from light. Do not use longer than 30 days after the first opening of the bottle. Keep out of the reach of children.

For cleansing and irrigating the skin and dirty wounds where an added surfactant effect is required.

Chlorhexidine & Chloroxylenol preparations

Chlorhexidine: Chlorhexidine is an antiseptic and disinfectant which is effective against a wide range of vegetative Gram-positive and Gram-negative organisms, some viruses and some fungi. It is ineffective against bacterial spores at room temperature, and acid-fast bacteria are inhibited but not killed. It is more active against Gram-positive than Gram-negative bacteria and some species of Pseudomonas and Proteus are relatively less susceptible. Chlorhexidine is most active at a neutral or slightly acid pH and its activity may be reduced by blood and other organic matter.

Cetrimide: Cetrimide is a quaternary ammonium disinfectant with properties typical of cationic surfactants. Solutions of these surfactants have emulsifying and detergent properties and bactericidal activity against both Gram-positive and Gram-negative organisms but higher concentrations are necessary to kill the latter. The combined detergent and antibacterial properties of cetrimide make it useful in cleansing dirty or infected wounds. It is however, relatively ineffective against bacterial spores, acid-fast bacteria, viruses and fungi.

Rinse the area to be cleaned with water, apply the minimum amount of irrigation necessary to cover the wound area and wash gently. Rinse again thoroughly. Apply to wound as necessary. Discard remaining solution after use.

Paediatric Use: Use with care in neonates, particularly in premature infants. Chlorhexidine may cause irritation or chemical burns.

Irritative skin reactions and hypersensitivity reactions to chlorhexidine have been reported. In the event that these reactions occur, discontinue use. Cetrimide may have a prolonging effect on the wound healing process.

Known hypersensitivity to either chlorhexidine or cetrimide. Do not use to irrigate the brain, meninges, eyes or perforated eardrum.

For external use only. Not for injection, for irrigation only. Not isotonic and is haemolytic. Cetrimide may have a prolonging effect on the wound healing process. Use of this antiseptic should be restricted to infection control and cleansing of wounds rather than general wound management.

Pregnancy: There are no adequate data from the use of chlorhexidine and cetrimide in pregnant women. The potential risk for humans is unknown but is most likely very low since chlorhexidine and cetrimide are poorly absorbed following topical application.

Breastfeeding: It is not known whether chlorhexidine and cetrimide are excreted in breast milk. There are no adequate data from the use of chlorhexidine and cetrimide in breast-feeding women. However, it is unlikely that the products are excreted in breast milk, since the products are poorly absorbed. After topical usage of the product, as a general precaution, rinse nipples thoroughly with water before breastfeeding.

While accidental ingestion is unlikely to cause any systemic effects due to poor absorption of chlorhexidine and cetrimide, ingestion of high concentrations could cause irritation of the gastrointestinal mucosa/gastritis. Gastric lavage might be needed. Symptomatic treatment should be employed. If swallowed, wash out mouth, drink plenty of milk or water and seek medical advice. In case of overdose, seek medical attention or contact a poison control centre.

Store below 25°C. Protect from light. Single use only. Discard unused portion.

This inhalation aerosol is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continues to have evidence of bronchospasm and who requires a second bronchodilator.

Combined bronchodilators

This inhalation aerosol is a combination of Salbutamol (as Sulphate) and Ipratropium Bromide. It is a hydrofluoroalkane (HFA) based environment friendly inhaler. Because it does not contain chlorofluorocarbon (CFC) as propellant which is one of the main reasons of ozone layer depletion.

Salbutamol is a short acting beta2-adrenergic bronchodilator and Ipratropium Bromide is an anticholinergic bronchodilator. When used in combination, Ipratropium Bromide prevents the increase in intracellular concentration of cyclic guanosine monophosphate, which are caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle. This inhalation aerosol is expected to maximize the response of the treatment in patients with chronic obstructive pulmonary disease (COPD) by reducing bronchospasm through two distinctly different mechanisms, anticholinergic (parasympatholytic) and sympathomimetic. Simultaneous administration of an anticholinergic (Ipratropium Bromide) and a beta 2-sympathomimetic (Salbutamol) is designed to benefit the patient by producing a greater bronchodilatory effect than when either drug is utilized alone at its recommended dosage.

Adult dose (Including the elderly): 2 puffs of Salpium 4 times a day (Patients may take additional puffs as required but a total number of puffs should not exceed 12 in 24 hours). Or as directed by the physician.

Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.

Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):

1. Take off the cap.
2. Shake the inhaler (at least six times) vigorously before each use.
3. If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
4. Breathe out as full as comfortably possible & hold the inhaler upright.
5. Place the actuator into mouth between the teeth and close lips around the mouthpiece.
6. While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
7. Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
8. If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
9. After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
10. Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.

Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

Due to presence of Salbutamol, mild tremor and headache have been reported. These usually disappear with continuous treatment. There have been very rare reports of treatments muscle cramp, hypersensitivity reactions including angioedema, urticaria, bronchospasm and hypotension.

For the presence of Ipratropium Bromide headache, influenza, chest pain, nausea, dyspnea, coughing, pharyngitis, sinusitis are rarely reported.

This inhalation aerosol is contraindicated in patients with a history of hypersensitivity to Soya-Lecithin or related food products such as soybean and peanut. This inhalation aerosol is also contraindicated in patients hypersensitive to any other components of the drug product or to atropine or its derivatives.

This inhalation aerosol has been used concomitantly with other drugs, including sympathomimetic bronchodilators, methylxanthines and steroids, commonly used in the treatment of COPD. No formal drug interaction studies have been performed with this inhalation aerosol and these or other medications commonly used in the treatment of COPD. Ipratropium Bromide should be co-administered cautiously with other anticholinergic agents and sympathomimetic agents, which may increase the risk of adverse cardiovascular effects. Beta-2-agonist containing drugs, like this inhalation aerosol, should be administrated with extreme caution in patients with non-potassium sparing diuretics, monoamine oxidase inhibitors or tricyclic antidepressants.

Ipratropium Bromide: Pregnancy category B. Studies have demonstrated no teratogenic effects as a result of ipratropium.

Salbutamol: Pregnancy category C. Salbutamol has been shown to be teratogenic in animals.

There are, however no adequate and well-controlled studies of Salpium Inhalation Aerosol (Salbutamol and Ipratropium Bromide combination) in pregnant woman. This inhalation aerosol should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known whether the components of the Salpium InhalationAerosol are excreted in human milk. As many drugs are excreted in human milk, Salpium should be cautiously administered to a nursing mother.

This inhalation aerosol contains Ipratropium Bromide and, therefore, should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction. Preparations containing sympathomimetic amines such as Salbutamol Sulphate should be used with caution in patients with convulsive disorders, hyperthyroidism, diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines.

The effects of overdosage are expected to be related primarily to Salbutamol Sulphate. Manifestations of overdosage with Salbutamol may include anginal pain, hypertension, hypokalemia and tachycardia.

Do not puncture, break or incinerate the pressurized canister even when apparently empty. Avoid storage in direct sunlight or heat. Store in a cool and dry place. Keep away from children. Keep away from eyes.

Specific combined vitamin preparations

Vitamin-B complex contains the most important members of the vitamin B group in pure form and in therapeutically balanced proportions. The members of the vitamin B group contained in Vitamin-B complex are components of enzyme systems that regulate various stages of carbohydrate, fat and protein metabolism, each of the components playing a specific biological role. Deficiency of B vitamin causes glossitis, stomatitis, cheilosis, polyneuritis, beriberi, pellagra and vascularisation of cornea.

Tablet/ capsule: usual recommended dose is 1-2 tablet/capsule 3 times daily or as directed by the physician.

Syrup: 2-3 teaspoonful daily or as directed by the physician.

Injection: It is for intramuscular and intravenous administration. Usual recommended dose is 2 ml daily or as directed by the physician. In addition with Thiamine, Riboflavin, Nicotinamide, Pyridoxine; injectable dosage from contains D-Panthenol 5 mg.

Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in Vitamin-B complex. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended level has been associated with gastrointestinal intolerance in some patients.

Vitamin-B complex is contraindicated in patients hypersensitive to any of its components.

As little as 5 mg pyridoxine daily can decrease the efficacy of levodopa in the treatment of parkinsonism. Therefore, Vitamin-B complex is not recommended for patients undergoing such therapy

It is safe to use Vitamin-B complex in pregnancy and lactation.

It is indicated in the following infections -

• Acute bacterial exacerbation of chronic bronchitis
• Acute community acquired pneumonia
• Pharyngitis or tonsillitis
• Skin and soft tissue infections
• Urinary tract infections
• Uncomplicated gonorrhea
• Acute maxillary sinusitis

Third generation Cephalosporins

Cefpodoxime is a third generation semi-synthetic Cephalosporin, exhibits activity against several Gram positive as well as Gram negative microorganisms. This compound is also stable in beta lactamase environment. Cefpodoxime exhibits exceptional activity against methicillin susceptible Staphylococci, Streptococcus pneumoniae, Haemophilus influenzae, Neisseria spp. and Moraxella catarrhalis.

Clavulanic acid is a natural inhibitor of beta lactamase which are produced by Streptomyces clavuligerus. It binds to beta lactamase moieties and inactivates them, thus restricting the Cefpodoxime destruction.

For adults (Age 12 years and older):

• Acute bacterial exacerbation of chronic bronchitis: 1 tablet 12 hourly for 10 days
• Acute community acquired pneumonia: 1 tablet 12 hourly for 14 days
• Pharyngitis or tonsillitis: ½ tablet 12 hourly for 5 to 10 days
• Skin and soft tissue infections: 2 tablet 12 hourly for 7 to 14 days
• Urinary tract infections: ½ tablet 12 hourly for 7 days
• Uncomplicated gonorrhea: Single dose
• Acute maxillary sinusitis: 1 tablet 12 hourly for 10 days

For children: Children 2 months to 12 years- 10 mg/kg/day in divided dose, every 12 hours.

Cefpodoxime is well tolerated. Most common gastrointestinal adverse effects are diarrhea, vomiting and abdominal pain.

Cefpodoxime is contraindicated in patients with known hypersensitivity to Cephalosporins.

Cefpodoxime should be administered with caution to patients receiving concurrent treatment with diuretics.

Concomitant administration of Cefpodoxime at high doses with antacids or H2 blockers reduces peak plasma levels of Cefpodoxime.

US FDA pregnancy category of Cefpodoxime & Clavulanic Acid is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.

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

It is indicated in the following infections -

• Acute bacterial exacerbation of chronic bronchitis
• Acute community acquired pneumonia
• Pharyngitis or tonsillitis
• Skin and soft tissue infections
• Urinary tract infections
• Uncomplicated gonorrhea
• Acute maxillary sinusitis

Third generation Cephalosporins

Cefpodoxime is a third generation semi-synthetic Cephalosporin, exhibits activity against several Gram positive as well as Gram negative microorganisms. This compound is also stable in beta lactamase environment. Cefpodoxime exhibits exceptional activity against methicillin susceptible Staphylococci, Streptococcus pneumoniae, Haemophilus influenzae, Neisseria spp. and Moraxella catarrhalis.

Clavulanic acid is a natural inhibitor of beta lactamase which are produced by Streptomyces clavuligerus. It binds to beta lactamase moieties and inactivates them, thus restricting the Cefpodoxime destruction.

For adults (Age 12 years and older):

• Acute bacterial exacerbation of chronic bronchitis: 1 tablet 12 hourly for 10 days
• Acute community acquired pneumonia: 1 tablet 12 hourly for 14 days
• Pharyngitis or tonsillitis: ½ tablet 12 hourly for 5 to 10 days
• Skin and soft tissue infections: 2 tablet 12 hourly for 7 to 14 days
• Urinary tract infections: ½ tablet 12 hourly for 7 days
• Uncomplicated gonorrhea: Single dose
• Acute maxillary sinusitis: 1 tablet 12 hourly for 10 days

For children: Children 2 months to 12 years- 10 mg/kg/day in divided dose, every 12 hours.

Cefpodoxime is well tolerated. Most common gastrointestinal adverse effects are diarrhea, vomiting and abdominal pain.

Cefpodoxime is contraindicated in patients with known hypersensitivity to Cephalosporins.

Cefpodoxime should be administered with caution to patients receiving concurrent treatment with diuretics.

Concomitant administration of Cefpodoxime at high doses with antacids or H2 blockers reduces peak plasma levels of Cefpodoxime.

US FDA pregnancy category of Cefpodoxime & Clavulanic Acid is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.

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

Tamsulosin Hydrochloride & Dutasteride capsule is indicated in-

• Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH).
• Reduction in the risk of acute urinary retention and surgery in patients with moderate to severe symptoms of BPH.

BPH/ Urinary retention/ Urinary incontinence

Tamsulosin & Dutasteride is a combination of two drugs with complementary mechanisms of action to improve symptoms in patients with Benign Prostatic Hyperplasia (BPH). Tamsulosin Hydrochloride, an antagonist of alpha_1A-adrenoreceptors and Dutasteride, a dual 5 alpha reductase inhibitor (5ARI). Treatment of BPH with alpha₁-adrenoreceptor blocking agents and 5ARIs results in an improvement in urine flow rate and a reduction in symptoms of BPH.

Tamsulosin: An alpha1-adrenoreceptor blocking agent that affects the dynamic component of BPH by inhibiting alpha₁-adrenoreceptors in the stromal prostatic smooth muscle and bladder neck. Blockade of these adrenoreceptors can cause smooth muscles in the bladder neck and prostate to relax. Specifically, Tamsulosin exhibits selectivity for both alpha _1A and alpha _1D receptors over the alpha_1B-adrenoreceptor subtype. These three adrenoreceptor subtypes have a distinct distribution pattern in human tissue. Whereas approximately 70% of the alpha₁-receptors in human prostate are of the alpha _1A subtype, the human bladder contains predominantly the alpha _1D subtype while blood vessels express predominantly alpha _1B subtype. It is further believed that blockade of the alpha _1D subtypes in the human obstructed bladder may be responsible for reducing detrusor overactivity and subsequent relief of storage symptoms.

Dutasteride: A synthetic 4-azasteriod compound is a competitive and specific inhibitor of both Type I and Type II 5 alpha-reductase isoenzymes that affects the static component of BPH by inhibiting the conversion of Testosterone to Dihydrotestosterone (DHT) by the enzyme 5 alpha-reductase. 5 alpha-reductase exists as 2 isoforms, Type I and Type II, both of which are present in the prostate. It has been observed that compared to normal tissue, the expression of both isoenzymes are increased in BPH tissue. Dissociation from this complex has been evaluated under in vitro and in vivo conditions and is extremely slow. Dutasteride lowers DHT levels and leads to a reduction in prostatic volume, thereby treating an underlying cause of BPH. Dutasteride does not bind to the human androgen receptor.

Adults (including elderly): The recommended dose is one capsule (Tamsulosin Hydrochloride 0.4 mg & Dutasteride 0.5 mg) taken orally approximately 30 minutes after the same meal each day. The capsules should be swallowed whole and not chewed or opened. Where appropriate, this capsule may be used to substitute concomitant Tamsulosin Hydrochloride and Dutasteride in existing dual therapy to simplify treatment. Where clinically appropriate, direct change from Tamsulosin Hydrochloride or Dutasteride monotherapy to this capsule may be considered.

Renal impairment: The effect of renal impairment on Tamsulosin-Dutasteride pharmacokinetics has not been studied. No adjustment in dosage is anticipated for patients with renal impairment.

Hepatic impairment: The effect of hepatic impairment on Tamsulosin-Dutasteride pharmacokinetics has not been studied so caution should be used in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the use of this capsule is contra-indicated.

The most common adverse reactions reported in subjects receiving combination therapy were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders and dizziness. The percentages of subjects with ejaculation disorders, decreased libido and impotence were higher in the combination therapy group compared with either monotherapy groups.

Tamsulosin-Dutasteride combination is contra-indicated in women and children and adolescents, patients with hypersensitivity to Dutasteride, other 5-alpha reductase inhibitors, Tamsulosin (including Tamsulosin- induced angio-edema), soya, peanut or any of other the excipients, patients with a history of orthostatic hypotension and patients with severe hepatic impairment.

Combination therapy should be prescribed after careful benefit risk assessment due to the potential increased risk of adverse events (including cardiac failure) and after consideration of alternative treatment options including monotherapies.

Cardiac failure: In two 4-year clinical studies, the incidence of cardiac failure was higher among subjects taking the combination of Dutasteride and an alpha blocker, primarily Tamsulosin, than it was among subjects not taking the combination. In these two trials, the incidence of cardiac failure was low (1%) and variable between the studies.

Effects on prostate specific antigen (PSA) and prostate cancer detection: Digital rectal examination, as well as other evaluations for prostate cancer or other conditions which can cause the same symptoms as BPH, must be performed on patients prior to initiating therapy with Tamsulosin-Dutasteride combination and periodically thereafter. Serum prostate-specific antigen (PSA) concentration is an important component in the detection of prostate cancer. Tamsulosin-Dutasteride combination causes a decrease in mean serum PSA levels by approximately 50%, after 6 months of treatment. Patients receiving Tamsulosin-Dutasteride combination should have a new PSA baseline established after 6 months of treatment. It is recommended to monitor PSA values regularly thereafter. Any confirmed increase from lowest PSA level while on Tamsulosin-Dutasteride combination may signal the presence of prostate cancer or noncompliance to therapy with Tamsulosin-Dutasteride combination and should be carefully evaluated, even if those values are still within the normal range for men not taking a 5 alpha-reductase inhibitor. In the interpretation of a PSA value for a patient taking Tamsulosin-Dutasteride combination, previous PSA values while on Dutasteride treatment should be sought for comparison. Treatment with Tamsulosin-Dutasteride combination does not interfere with the use of PSA as a tool to assist in the diagnosis of prostate cancer after a new baseline has been established. Total serum PSA levels return to baseline within 6 months of discontinuing treatment. The ratio of free to total PSA remains constant even under the influence of Tamsulosin-Dutasteride combination. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men undergoing Tamsulosin-Dutasteride combination therapy, no adjustment to its value appears necessary.

Prostate cancer and high grade tumours: Results of one clinical study in men at increase risk of prostate cancer revealed a higher incidence of Gleason 8-10 prostate cancers in Dutasteride treated men compared to placebo. The relationship between Dutasteride and high grade prostate cancer is not clear. Men taking Tamsulosin-Dutasteride combination should be regularly evaluated for prostate cancer risk including PSA testing.

Renal impairment: The treatment of severely renally impaired patients (creatinine clearance of less than 10 ml/min) should be approached with caution as these patients have not been studied.

Hypotension: Orthostatic- As with other alpha-blockers, a reduction in blood pressure can occur during treatment with Tamsulosin, as a result of which, rarely, syncope can occur. Patients beginning treatment with Tamsulosin-Dutasteride combination should be cautioned to sit or lie down at the first signs of orthostatic hypotension (dizziness, weakness) until the symptoms have resolved. In order to minimize the potential for developing postural hypotension the patient should be haemodynamically stable on alpha-blocker therapy prior to initiating use of PDE5 inhibitors. Symptomatic: Caution is advised when alpha adrenergic blocking agents including Tamsulosin are coadministered with PDE5 inhibitors (e.g. sildenafil, tadalafil, vardenafil). Alpha adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension.

Intraoperative Floppy Iris Syndrome: Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients on or previously treated with Tamsulosin. IFIS may lead to increased procedural complications during the operation. The initiation of therapy with Tamsulosin-Dutasteride combination in patients for whom cataract surgery is scheduled is therefore not recommended. Discontinuing Tamsulosin 1-2 weeks prior to cataract surgery is anecdotally considered helpful, but the benefit and duration of stopping therapy prior to cataract surgery has not yet been established. Leaking Capsule: Dutasteride is absorbed through the skin, therefore, women, children and adolescents must avoid contact with leaking capsules. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water.

Hepatic impairment: Tamsulosin-Dutasteride combination has not been studied in patients with liver disease. Caution should be used in the administration of Tamsulosin-Dutasteride combination to patients with mild to moderate hepatic impairment.

Breast neoplasia: Breast cancer has been reported in men taking Dutasteride in clinical trials and during the post-marketing period. Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps or nipple discharge. Currently it is not clear if there is a causal relationship between the occurrence of male breast cancer and long term use of Dutasteride.

There have been no drug interaction studies for Dutasteride-Tamsulosin combination.

Effects of other drugs on the pharmacokinetics of Dutasteride: Use together with CYP3A4 and/or P-glycoprotein-inhibitors: Dutasteride is mainly eliminated via metabolism. In vitro studies indicate that this metabolism is catalysed by CYP3A4 and CYP3A5. No formal interaction studies have been performed with potent CYP3A4 inhibitors. However, in a population pharmacokinetic study, Dutasteride serum concentrations were on average 1.6 to 1.8 times greater, respectively, in a small number of patients treated concurrently with verapamil or diltiazem (moderate inhibitors of CYP3A4 and inhibitors of P-glycoprotein) than in other patients. Long-term combination of Dutasteride with drugs that are potent inhibitors of the enzyme CYP3A4 (e.g. ritonavir, indinavir, nefazodone, itraconazole, ketoconazole administered orally) may increase serum concentrations of Dutasteride. Further inhibition of 5-alpha reductase at increased Dutasteride exposure, is not likely. However, a reduction of the Dutasteride dosing frequency can be considered if side effects are noted. It should be noted that in the case of enzyme inhibition, the long half-life may be further prolonged and it can take more than 6 months of concurrent therapy before a new steady state is reached. Administration of 12 g cholestyramine one hour after a 5 mg single dose of Dutasteride did not affect the pharmacokinetics of Dutasteride.

Effects of Dutasteride on the pharmacokinetics of other drugs: In a small study (N=24) of two weeks duration in healthy men, Dutasteride (0.5 mg daily) had no effect on the pharmacokinetics of Tamsulosin or terazosin. There was also no indication of a pharmacodynamic interaction in this study. Dutasteride has no effect on the pharmacokinetics of warfarin or digoxin. This indicates that Dutasteride does not inhibit/induce CYP2C9 or the transporter P-glycoprotein. In vitro interaction studies indicate that Dutasteride does not inhibit the enzymes CYP1A2, CYP2D6, CYP2C9, CYP2C19 or CYP3A4. Tamsulosin: Concomitant administration of Tamsulosin Hydrochloride with drugs which can reduce blood pressure, including anaesthetic agents, PDE5 inhibitors and other alpha-1 adrenergic blockers could lead to enhanced hypotensive effects. Tamsulosin-Dutasteride should not be used in combination with other alpha-1 adrenergic blockers. Concomitant administration of Tamsulosin Hydrochloride (0.4 mg) and cimetidine (400 mg every six hours for six days) resulted in a decrease in the clearance (26%) and an increase in the AUC (44%) of Tamsulosin Hydrochloride. Caution should be used when Tamsulosin-Dutasteride is used in combination with cimetidine. A definitive drug-drug interaction study between Tamsulosin Hydrochloride and warfarin has not been conducted. Results from limited in vitro and in vivo studies are inconclusive. Caution should be exercised with concomitant administration of warfarin and Tamsulosin Hydrochloride. No interactions have been seen when Tamsulosin Hydrochloride was given concomitantly with either atenolol, enalapril, nifedipine or theophylline. Concomitant furosemide brings about a fall in plasma levels of Tamsulosin, but as levels remain within the normal range posology need not be adjusted. In vitro neither diazepam nor propranolol, trichlormethiazide, chlormadinon, amitryptyline, diclofenac, glibenclamide and simvastatin change the free fraction of Tamsulosin in human plasma. Neither does Tamsulosin change the free fractions of diazepam, propranolol, trichlormethiazide, and chlormadinon. No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions, involving amitriptyline, salbutamol and glibenclamide. Diclofenac however, may increase the elimination rate of Tamsulosin.

Tamsulosin-Dutasteride combination is contra-indicated for use by women. There have been no studies to investigate the effect of Tamsulosin-Dutasteride combination on pregnancy, lactation and fertility. The following statements reflect the information available from studies with the individual components. Fertility: Dutasteride has been reported to affect semen characteristics (reduction in sperm count, semen volume, and sperm motility) in healthy men. The possibility of reduced male fertility cannot be excluded. Effects of Tamsulosin Hydrochloride on sperm counts or sperm function have not been evaluated.

Pregnancy: As with other 5 alpha reductase inhibitors, Dutasteride inhibits the conversion of testosterone to dihydrotestosterone and may, if administered to a woman carrying a male foetus, inhibit the development of the external genitalia of the foetus. Small amounts of Dutasteride have been recovered from the semen in subjects receiving Dutasteride. It is not known whether a male foetus will be adversely affected if his mother is exposed to the semen of a patient being treated with Dutasteride. As with all 5 alpha reductase inhibitors, when the patient’s partner is or may potentially be pregnant it is recommended that the patient avoids exposure of his partner to semen by use of a condom. Administration of Tamsulosin Hydrochloride to pregnant female rats and rabbits showed no evidence of foetal harm.

Lactation: It is not known whether Tamsulosin or Dutasteride are excreted in human milk.

No data are available with regard to over dosage of Tamsulosin-Dutasteride combination. The following statements reflect the information available on the individual components.

Dutasteride: In volunteer studies, single daily doses of Dutasteride up to 40 mg/day (80 times the therapeutic dose) have been administered for 7 days without significant safety concerns. In clinical studies, doses of 5 mg daily have been administered to subjects for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.5 mg. There is no specific antidote for Dutasteride, therefore, in suspected over dosage symptomatic and supportive treatment should be given as appropriate.

Tamsulosin: Acute overdose with 5 mg Tamsulosin Hydrochloride has been reported. Acute hypotension (systolic blood pressure 70 mm Hg), vomiting and diarrhoea were observed which were treated with fluid replacement and the patient could be discharged the same day. In case of acute hypotension occurring after over dosage cardiovascular support should be given. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this does not help then volume expanders, and when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as Tamsulosin is very highly bound to plasma proteins. Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.

Store in a cool 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.