Paracetamol

Indication:

Fever, headache, toothache, earache, bodyache, myalgia, dysmenorrhoea, neuralgia and sprains. Pain of colic, back pain, chronic pain of cancer, inflammatory pain, and post-vaccination pain and fever of children. Rheumatism and osteoarthritic pain & stiffness of joints in fingers, hips, knees, wrists, elbows, feet, ankles and top & bottom of the spine.

Dosage & Administration:

 Tablet: Adult 1-2 tablets every 4 to 6 hours up to a maximum of 4 g (8 tablets) daily. Children (6-12 years) 1/2 to 1 tablet 3 to 4 times daily. XR Tablet: 2 tablet every 6 to 8 hourly upto a maximum of 6 tablets daily. Syrup and Suspension: Children Under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if

jaundiced) 3 to 4 times daily. 3 months to below 1 year : 1/2 to 1 teaspoonful 3 to 4 times daily. 1-5 years: 1-2 teaspoonful 3 to 4 times daily. 6-12 years : 2-4 teaspoonful 3 to 4 times daily. Adults 4-8 teaspoonful 3 to 4 times daily. Paediatric Drop: Children upto 3 months: 0.5 ml (40 mg) 4 to 11 months:

1.0 ml (80 mg). 1 to 2 years: 1.5 ml (120 mg) Dose can be repeated, every 4 hours.

Suppository: Suppository should be administered rectaly. Children 3 months -

1 year : 60-120 mg 4 times daily. Children below 5 years : 125-250 mg, 4 times daily. Children 6-12 years : 250-500 mg, 4 times daily. Adults and children over 12 years : 0.5 - 1 mg, 4 times daily.

Contraindication & Precaution:

 Known sensitivity to paracetamol.

Side Effect:

Side Effects are significantly mild, though haematological reactions

have been reported. Pancreatitis, skin rashes, and other allergic reactions occur

alcoholics or in patients taking other antiepilectic medications.

Precaution:

 Should be given cautiously in the following cases: In patients with hepatic or renal failure, in patients taking other hepatotoxic medication. Prolonged

use of the drug without consulting a physician should be avoided.

Preparation:

Paracetamol 500 mg & Caffeine 65 mg.

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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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