Ciprofloxacin Injection USP 200 mg/10Oml

COMPOSITION: Each 5mL of LERZIN contains 5mg cetirizine dihydrochloride.

PHARMACOLOGICAL CLASSIFICATION: Antihistaminic.

PHARMACOLOGICAL ACTION

Cetirizine is a metabolite of hydroxyzine. It is a second-generation reversible, competitive inhibitor of histamine at the histamine-1 (H1) receptor. Cetirizine competes with histamine for the H1-receptor site. Cetirizine prevents, but does not reverse, pharmacological responses mediated by histamine, at the H1 receptor. Pharmacokinetics:

Cetirizine is well absorbed from the gastro-intestinal tract and peak plasma concentrations are reached within and an hour after oral administration. Pharmacokinetics are linear, with plasma concentrations increasing proportionately with increasing doses. The terminal half-life in adults is approximately 10 hours; in children aged 6 to 12 years 6 hours; in children aged 2 to 6 years, 5 hours. Cetirizine is eliminated faster in children, and slower in patients with hepatic or renal impairment (creatinine clearance <40 mL/min), with a resultant increase in half-life and decrease in clearance. Cetirizine does not undergo extensive first-pass metabolism. The cumulative urinary excretion represents about two thirds of the dose given in both adults and children.

INDICATIONS: LERZIN syrup is indicated for symptomatic relief of allergic conditions such as allergic rhinitis, and allergic skin conditions such as urticaria.

CONTRA-INDICATIONS

• Hypersensitivity to LERZIN syrup or any of the ingredients.
• Hypersensitivity to hydroxyzine.
• Lactating women, since the active ingredient is excreted in breast-milk.
• Pregnancy, as safety has not been established.
• Children under the age of two years, as safety and efficacy have not been demonstrated.

WARNINGS

This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents. The patient's ability to perform hazardous activities requiring mental alertness or physical coordination such as driving or operating machinery may be impaired.

Porphyria: Use with caution.

INTERACTIONS

Concomitant use of alcohol and other sedating agents should be avoided. There is no evidence of an interaction between cetirizine and cimetidine, ketoconazole, erythromycin, azithromycin, diazepam, glipizide, and pseudoephedrine.

PREGNANCY AND LACTATION: Safety in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE

• Adults or children 12 years of age or older: 10 mg (10 mL) once daily
• Children 6 to 12 years old: 10 mg (10 mL) daily, either as a single dose or as divided doses of 5 mL in the morning and 5 mL in the evening.
• Children aged 2-6 years: 5 mg (5 mL) daily, either as a single dose or as divided dose: of 2.5 mL in the morning and 2.5 mL in the evening.
• No dose adjustment is necessary in healthy elderly patients with normal renal function.

Dosage in Renal impairment: In patients with renal impairment, where the creatinine clearance is less than 40 mL/min, the recommended daily dose of cetirizine should be halved.

Dosage in Hepatic impairment: In moderate to severe hepatic impairment half the recommended daily dose should be used.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS

Side-effects:

• Nervous system disorders
• Less frequent: dizziness Frequency unknown: drowsiness, fatigue, anxiety, nervousness Vascular disorders Frequency unknown: headache, angioedema
• Respiratory, thoracic and mediastinal disorders
• Frequency unknown: thickening of mucous
• Gastrointestinal disorders
• Less frequent: dry mouth, increased appetite, nausea, gastrointestinal discomfort
• Skin and subcutaneous tissue disorders
• Less frequent: skin rash
• Frequency unknown: urticaria, pruritus General disorders
• Frequency unknown: malaise, asthenia

Special precautions: LERZIN syrup lacks significant sedative effects. Patients should be warned, however, that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks. This effect may be compounded by simultaneous intake of alcohol or other central nervous system depressants.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OFITS TREATMENT

Drowsiness is an expected symptom of overdose. Overdose in children may produce agitation, somnolence, pruritus, rash, urinary retention, fatigue, tremor, and tachycardia. In the case of massive overdose, gastric lavage should be performed together with the usual supportive measures. There is no specific antidote. Cetirizine is not effectively removed by dialysis.

FURTHER TREATMENT IS SYMPTOMATIC AND SUPPORTIVE.

PRESENTATION:

LERZIN syrup 5 mg/5mL is available in 30 ml amber glass bottles with a white, tamper evident/ROPP screw cap with dispenser contained in a skillet.

STORAGE INSTRUCTIONS:

Store below 30°C. Protect from light. Keep container tightly closed.

KEEP OUT OF REACH OF CHILDREN.

CONTENTS OF FORMULATION

LERZIN Syrup contain Ceterone Hydrochloride, Sucrose, Sodium Methyl Paraben, Sodium Benzoate, Flavor Raspberry Sweet, Sodium Edetate.

Manufactured by Pharmanova Limited 3, Okodan Street, Osu-Manhean, Accra- Ghana