Esomeprazole

Esomeprazole

Indication: Nexum is indicated for the treatment of - Gastroesophageal Reflux Disease (GERD), Healing of Erosive Esophagitis, Maintenance of healing of Erosive Esophagitis, Symptomatic Gastroesophageal Reflux Disease (GERD), Risk Reduction of NSAIDassociated gastric ulcer & H. pylori eradication (Triple therapy).

Dosage & Administration: Tablet and capsule: Recommended adult dosage schedule of Esomeprazole is –

Indications	Dose	Frequency
Gastroesophageal Reflux Disease (GERD)
Healing of erosive esophagitis	20 mg or 40 mg	Once daily for 4 to 8 weeks*
Maintenance of healing of erosive esophagitis	20 mg	Once daily**
Symptomatic GERD	20 mg	Once daily for 4 weeks ***
Risk Reduction of NSAID associated gastric ulcer	20 mg or 40 mg	Once daily for up to 6 months**
H. pylori eradication (Triple therapy)
Esomeprazole	20 mg	Twice daily for 10 days
Amoxicillin	1000 mg	Twice daily for 10 days
Clarithromycin	500 mg	Twice daily for 10 days

Paediatric use (12 years and older)

Short term treatment of GERD: 20 mg or 40 mg once daily for up to 8 weeks.

• The majority of patients are healed within 4 to 8 weeks. For patients who do not heal

after 4-8 weeks, an additional 4-8 weeks treatment may be considered.

• Controlled studies did not extend beyond 6 months.

• If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.

Injection

Duodenal ulcer, gastric ulcer, gastrointestinal lesions refractory to H2 blockers, Zollinger-Ellison syndrome	40 mg per day intravenously
Reflux esophagitis	20-40 mg per day intravenously

Direction for use of IV Injection

Esomeprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Esomeprazole injection 40 mg should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 5 ml 0.9% Sodium Chloride Injection to the vial containing powder.

After reconstitution the injection should be given slowly over a period of at least 3 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30oc) for a maximum 12 hours. Half of the IV injection should be used when 20 mg to be administered.

Direction for use of IV Infusion

Esomeprazole IV 40 mg should be given as an intravenous infusion over a period of 10 to 30 minutes. Esomeprazole IV should be reconstituted with 5 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 5% Dextrose Injection or 0.9% Sodium Chloride Injection or Lactated Ringer’s Injection to a final volume of 50 ml. The

reconstituted solution may be stored at room temperature (up to 30oc) for a maximum 12 hours prior to dilution. The admixed solution may be stored at room temperature (up to 30oc) and must be used within 12 hours when reconstituted with 0.9% Sodium Chloride Injection or Lactated Ringer’s Injection and within 6 hours when reconstituted with 5% Dextrose Injection.

Contraindication & Precaution:

Esomeprazole is contraindicated in those patients who have known hypersensitivity to any other components of the formulation. Exclude the possibility of malignancy when gastric ulcer is suspected and before treatment for dyspepsia.

Side-Effect:

Side Effects reported with Esomeprazole include headache, diarrhea and abdominal pain.

Use in Pregnancy & Lactation:

US FDA Pregnancy Category - ‘B’. This drug should be used during pregnancy only if clearly needed. Because Esomeprazole is likely to be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Preparation:

20 mg Tablet & Capsule, 40 mg Tablet & Capsule and 40 mg IV Injection.

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Diphenhydramine

Diphenhydramine

Indication

For the treatment of following:

1) Seasonal, perennial & vasomotor rhinitis, 2) urticaria, angioneurotic edema, anaphylaxis, 3) pruritus, 4) preanesthetic medication, emesis, motion sickness, 5) miscellaneous including meniere’s

diseases and parkinsonism, 6) cough & cold. Sometimes it may use as a night time sleep aid and for the short-term management of insomnia.

Dosage and Administration

Most allergic conditions are controlled with 25 to 50 mg i.e., (12.5 to 25 ml of syrup) 3 to 4 times a day. Children 6 to 12 years of age : 10 mg i.e.(5 ml of syrup) 3 to 4 times a day.Children 1 to 6 years of age: 5 mg i.e.,

(2.5 ml of syrup) 3 to 4 times a day. In motion sickness: Adults : 25 to 50 mg 3 to 4 times a day. Children (above 9.1 kg): 12.5 to 25 mg 3 to 4 times a day (5mg/ kg/24 hours).

In parkinsonism: Adults: 25 to 50 mg 3 to 4 times a day. Children (above 9.1 kg) : 12.5 to 25 mg 3 to 4 times a day (5mg/ kg/ 24hours).In insomnia: Adults and children over 12 years of old : A dose of 20 to 50 mg is used

as hypnotic in insomnia.

In cough & cold: Adults: 25 mg every 4 hrs. Not to exceed 150 mg in 24 hours. Children (6 to 12 years) : 12.5 mg every 4 hours. Not to exceed 75 mg in 24 hours. Children (2 to 6 years): 6.25 mg every 4 hours.

Contraindication and Precaution

Contraindicated for the premature or newborn infants. Any patients in whom drowsiness is undesirable e.g. drivers, machine operators. Patients with known hypersensitivity to Diphenhydramine or any components of the product. Patients should be cautioned not to operate vehicles or hazardous machinery until their response to the drug has been determined.

Drug Interaction

Antituberculous agent, para-aminosalicylic acid (PAS), alcohol, other CNS depressants (hypnotics, sedatives, tranquilizers, etc), MAO inhibitors.

Side Effect

Side Effects include drowsiness, dizziness, dryness of mouth, blurred vision, nausea and vomiting.

Uses in Pregnancy & Lactation

Should be used in pregnancy only if clearly needed. Use in lactating mother is not recommended.

Preparation

10 mg/5 ml Syrup

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Carbonyl Iron + Folic Acid + Zinc.

Indication


Treatment and prophylaxis of Iron, Folic Acid and Zinc deficiencyespecially during pregnancy and lactation.


Dosage & Administration

Adult : one capsule daily before food or as directed by the physician.


Contraindication & Precaution

Known hypersensitivity to any of its component or those with Iron overload. Special care with generalized weakness due to vitamins and minerals deficiency.

Dosage & Administration

Adult: One Capsule daily before food or as directed by the physician.


Contraindication & Precaution

It is contraindicated in patients with known hypersensitivity to any of its component
or those with Iron overload. Special care should be taken in patients with Iron overload states, such as haemochromatosis, haemolytic anaemia or red blood cell aplasia. Failure to response to the treatment requires further investigations to exclude other causes of anaemia. In patients with renal failure there may be the risk of Zinc accumulation.


Side Effect


Gastrointestinal irritations such as nausea, anorexia, vomiting, discomfort, constipation and diarrhea may occur. Patients may complain of dark stool. Carbonyl Iron pellets incorporated into the capsules to reduce the possibility of gastrointestinal irritations. Rarely there may be allergic reactions.


Use in Pregnancy & Lactation

Use of any drug during first trimester of pregnancy should be avoided if possible Thus administration of Iron during the first trimester requires definite evidence of Iron deficiency. Prophylaxis of Irondeficiency where inadequate diet calls for supplementary Zinc and Folic acid is justified during the remainder of pregnancy.


Drug Interaction

Carbonyl Iron decreases the absorption of tetracyclineantibiotics, quinolone antibiotics, levodopa, levothyroxine, methyldopa andpenicillamine. Folic Acid interacts with antiepileptics, so plasma concentrations of phenobarbital, phenytoin and primidone Polymaltose Complex, Folic Acid and Zinc


Indication

Prevention and treatment of Iron, Folic Acid and Zinc deficiencies.


Dosage & Administration


One tablet daily. Two tablets may be required a day in severe cases or as recommended by the physician.


Contraindication and Precaution

In patients with a known hypersensitivity to any of the ingredients of this product. Dark coloration of stool may occur which is without clinical significance.


Side Effect

Occasionally gastrointestinal irritation such as sensation of repletion,pressure in the epigastric region, nausea, constipation or diarrhoea may occur.


Drug Interaction

No interaction has been observed.


Use in Pregnancy and Lactation

Use of any drug during the first trimester of pregnancy should be avoided if possible.Thus administration of Iron in the first trimester requires definite evidence of Iron deficiency. Prophylaxis of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic Acid is justified during the remainder of
pregnancy.



Preparation

Each film coated tablet contains Iron (III) Hydroxide Polymaltose Complex 188 mg equivalent to 47 mg elemental Iron, Folic Acid 0.50 mg and Zinc Sulphate Monohydrate 61.80 mg equivalent to 22.50 mg elemental Zinc.

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Azithromycin

Indication

Bronchitis and pneumonia, sinusitis and pharyngitis/ tonsillitis, otitis media, skin and soft tissue infections, sexually transmitted diseases.


Dosage & Administration

Adults: 500 mg once daily for 3 days. Children: 10 mg/ kg body weight once daily for 3 days.


Contraindication & Precaution


Known hypersensitivity, should not be used in patients with hepatic disease Avoid concomitant administration with terfenadine or astemizole. Precaution should be taken in patients with more severe renal impairment.


Side Effect

Nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhea, headache, dizziness and skin rashes, reversible elevations in liver transaminases.


Drug Interaction


Antacids, Ergot Derivatives, Digoxin & Cyclosporin, Antihistamines.


Use in Pregnancy and Lactation

The initial treatment of chlamydial cervicitis in pregnancy. In other infections, azithromycin should be used only when clearly needed. Exercise caution when administering to a nursing woman.


Preparation

500 mg Tablet, 250 mg Capsule, 200 mg/5 ml Suspension. patients. Other adverse reactions were reported burning, stinging and irritation upon instillation, contact dermatitis, corneal erosion, dry eye, dysgeusia, nasal congestion, ocular discharge, punctuate keratitis, and sinusitis in less than 1% of patients.

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Nitazoxanide.

Indication

Diarrhea caused by Cryptosporidium parvum and Giardia lamblia, Amebiasis and helminth infections.


Dosage & Administration

Age 1 - 3 years: 5 ml (100 mg) twice daily for 3 days, Age 4 - 11 years : 10 ml (200 mg) twice daily for 3 days, Age >12 years : 25 ml or 1 tablet (500 mg) twice daily for 3 days.


Contraindication & Precaution

Known hypersensitivity to Nitazoxanide or any other ingredient in the formulations. Should be administrated with caution to patients with hepatic, renal and biliary disease.


Side Effect

Abdominal pain, diarrhea vomiting and headache have been reported rarely.


Use in Pregnancy & Lactation

Pregnancy category B : This drug should be used during pregnancy only if clearly needed. Nursing mother: Caution should be exercised when Nitazoxanide is administrated to a nursing woman.


Drug Interaction

Caution should be u sed when administering Nitazoxanide concurrently with other highly plasmaprotein bound drugs.


Preparation


 500 mg Tablet, 30 ml & 60 ml Suspension (100 mg/5 ml).

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. Omeprazole

.

Indication

Omeprazole Capsule and tablet is indicated for gastroesophageal reflux disease including reflux esophagitis, acid reflux disease, duodenal and benign gastric ulcers, Helicobacter pylori eradication regimens in peptic ulcer disease, prophylaxis of acid aspiration, Zollinger-Ellison Syndrome and for the treatment of NSAID-associated gastric ulcers, duodenal ulcers or gastroduodenal erosions. Omeprazole IV is indicated primarily for the treatment of Zollinger-Ellison syndrome, and may also be used for the treatment of gastric ulcer, duodenal ulcer and reflux esophagitis.

Dosage & Administration

 Omeprazole Capsule and tablet:  should be taken before meal.

Disease Dosage and administration

Gastroesophageal reflux disease including reflux esophagitis	The usual dosage is 20 mg  once daily. The majority of Patients are healed after 4 weeks. For those patients not fully healed after the initial course, healing usually occurs during a further 4-8 weeks treatment.  has also been used in a dose of 40 mg once daily in patients with reflux esophagitis refractory to other therapy. Healing usually occurred within 8 weeks. Patients can be continued at a dosage of 20 mg once daily.
Acid reflux disease	For long-term management  10 mg once daily is recommended, increasing to 20 mg if symptoms return.
Duodenal and benign gastric ulcers	The usual dose is 20 mg  once daily. The majority of patients with duodenal ulcer are healed after 4 weeks. The majority of patients with benign gastric ulcer are healed after 8 weeks. In severe or recurrent cases the dose may be increased to 40 mg daily. Long-term therapy for patients with a history of recurrent duodenal ulcer is recommended at a dosage of 20 mg once daily. For prevention of relapse in patients with duodenal ulcer the recommended dose is  10 mg once daily, increasing to 20 mg once daily, if symptoms return.
Helicobacter pylori eradication regimens in peptic ulcer disease	is recommended at a dose of 40 mg once daily or 20 mg twice daily in association with antimicrobial agents Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for 7 to 14 days.
Prophylaxis of acid aspiration	For patients considered to be at risk of aspiration of the gastric contents during general anaesthesia, the recommended dosage is  40 mg on the evening before surgery followed by 40 mg 2-6 hours prior to surgery.
Zollinger-Ellison syndrome	The recommended initial dosage is 60 mg  once daily. The dosage should be adjusted individually and treatment continued as long as clinically indicated. More than 90% of patients with severe disease and inadequate response to other therapies have been effectively controlled on doses of 20-120 mg daily. With doses above 80 mg daily, the dose should be divided and given Twice daily.
For the treatment of NSAIDassociated gastric ulcers, duodenal ulcers or gastroduodenal erosions	The recommended dosage of  is 20 mg once daily. Symptom resolution is rapid and in most patients healing occurs Within 4 weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further 4 Weeks treatment. For the prophylaxis of NSAID-associated gastric ulcers, duodenal ulcers, gastroduodenal erosions and dyspeptic symptoms in patients with a previous history of gastroduodenal lesions who require continued NSAID treatment, the recommended dosage of  is 20 mg once daily.
Children GERD or other acid-related disorders	The recommended dose for pediatric patients 1 years of age and older is as follows: Age Body Weight Dose > 1 year 10 - 20 kg 10 mg once daily, if needed, 20 mg once daily > 2 year > 20 kg 20 mg once daily, if needed, 40 mg once daily
IV Injection Duodenal ulcer, gastric ulcer or reflux esophagitis	In patients with duodenal ulcer, gastric ulcer or reflux esophagitis where oral medication is inappropriate, IV 40 mg once daily is recommended.
Zollinger-Ellison Syndrome (ZES)	In patients with Zollinger-Ellison syndrome the recommended initial dose of  given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided and given twice daily.

Direction For Use Of IV Injection

lyophilized powder and water for injection is for intravenous administration

only and must not be given by any other route.  injection 40 mg should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2-5 minutes at a maximum rate of 4 ml per minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.

Direction For Use Of IV Infusion

 IV infusion 40 mg should be given as an intravenous infusion over a period

of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% dextrose for infusion. The solution should be used within 12 hours when  is dissolved in saline and within 6 hours when dissolved in 5% dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.

Contraindication And Precaution

There are no known contraindications to the use of .When gastric ulcer is suspected, the possibility of malignancy should be excluded before treatment with  is instituted as treatment may alleviate symptoms and delay diagnosis.

Side-Effect

Omeprazole Is well tolerated. Nausea, diarrhoea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.

Use in Pregnancy & Lactation

Omeprazole Can be used during pregnancy. is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.

Preparation

 Omeprazole 20 mg Capsule & DR Tablet, 40 mg Capsule & 40 mg IV Injection.

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