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Rankof Day & Night

Quick Overview

Our aim is to reach out to the globe within shortest possible time frame


To promote this objective, not only we distribute and market our Anti-Cold range of products globally through our distribution channels but we also undertake ‘contract manufacturing’& ‘formulation development ’of our wide range of generic products such as Rankof Day & Night which contains Paracetamol, Caffeine & Phenylephrine Hydrochloride.

Rankof Day & Night

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Details

COMPOSITION:

Each combipack contains:

Day Tablets:

Each film coated tablet contains:

Paracetamol BP                                    500 mg

Caffeine BP                                            32 mg 

Phenylephrine Hydrochloride BP          10 mg

Excipients                                               q.s.

Colour: Quinoline yellow, Titanium Dioxide BP

 

Night Tablets:

Each film coated tablet contains:

Paracetamol BP                                    500 mg

Phenylephrine Hydrochloride BP          10 mg

Chlorpheniramine Maleate BP                2 mg  

Excipients                                               q.s.

Colour: Brilliant Blue FCF, Titanium Dioxide BP

 

CATEGORY: Antipyretic, Analgesic, Decongestant, Antihistaminic 

PHARMACOLOGY

PHARMACODYNAMICS:

Active ingredients of Rankof Day and Night Tablets are clinically proven analgesic-antipyretic, decongestant and an antihistamine.

Paracetamol is an analgesic and antipyretic agent. It causes selective inhibition of COX – 3 in the brain & spinal cord and inhibits prostaglandin synthesis. Paracetamol produces analgesia by elevation of the pain threshold and antipyretic effect through action on the hypothalamic heat-regulating center.

Caffeine enhances the analgesic activity of Paracetamol and serves to reduce incidence of sedation due to Chlorphenamine maleate.

Phenylephrine is sympathomimetic vasoconstrictor that has been used as a decongestant. It is a relatively selective alpha-adrenoceptor agonist. The majority of the sympathomimetic action is due to direct stimulation of the adrenoceptors and relatively little is due to an indirect effect via release of noradrenaline. Its pressor action is weaker than that of noradrenaline but of longer duration. At therapeutic doses, it does not cause significant stimulation of the central nervous system.

Chlorphenamine provides prompt relief of itchy-watery eyes, runny nose, sneezing, itching of the nose or throat due to respiratory allergies.

 

PHARMACOKINETICS:

Paracetamol

Absorption: Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. 

Distribution:  Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.

Metabolism: It is metabolized in the liver. A minor hydroxylated metabolite which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following paracetamol over-dosage and cause liver damage.

Elimination: It is excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life varies from about 1 to 4 hours. 

Caffeine

Absorption: Readily absorbed after oral or parenteral administration. The peak plasma level for caffeine range from 6-10mg/L and the mean time to reach peak concentration ranged from 30 minutes to 2 hours.

Distribution: Volume of distribution is 0.8 to 0.9 L/kg in infants and 0.6 L/kg in adults. Protein binding is low (25 to 36%).

Metabolism: Hepatic cytochrome P450 1A2 (CYP 1A2) is involved in caffeine biotransformation. About 80% of a dose of caffeine is metabolized to paraxanthine (1, 7-dimethylxanthine), 10% to theobromine (3, 7-dimethylxanthine), and 4% to theophylline (1, 3-dimethylxanthine).

Elimination: In young infants, the elimination of caffeine is much slower than that in adults due to immature hepatic and/or renal function. Half-life is 3 to 7 hours in adults, 65 to 130 hours in neonates.

Phenylephrine Hydrochloride

Absorption: Completely absorbed after oral administration. It has a reduced bioavailability (compared to pseudoephedrine) following oral administration due to significant first-pass metabolism in the intestinal wall. Compared to IV administration, bioavailability is approximately 38%.

Distribution: Peak serum concentrations are achieved approximately 0.75-2 hours following oral administration. Phenylephrine should be administered parenterally to achieve cardiovascular effects. Occasionally, systemic effects are observed following oral inhalation. 95% binding-plasma proteins.

Metabolism: Undergoes extensive first-pass metabolism in the intestinal wall and extensive metabolism in the liver. Sulfate conjugation, primarily in the intestinal wall and oxidative metabolism by monoamine oxidase (MAO) represent the principle routes of metabolism. Glucuronidation occurs to a lesser extent.

Elimination: Phenylephrine and its metabolites are mainly excreted in urine. Half-life is 2.1 to 3.4 hours.

Chlorphenamine Maleate :

Absorption: Chlorphenamine Maleate is absorbed relatively slowly from the gastrointestinal tract, peak plasma concentration occurring about 2.5 to 6 hours after administration by mouth.

Distribution: About 70% of chlorphenamine in the circulation is bound to plasma protein.

Metabolism: Chlorphenamine appears to undergo considerable first-pass metabolism. Primarily hepatic via Cytochrome P450 (CYP450) enzymes.

Elimination: Half –life is 21-27 hours. Unchanged chlorphenamine and metabolites are excreted primarily in the urine; excretion is dependent on urinary pH and flow rate.

 

INDICATIONS:

Rankof Day Tablets provide relief from cold and flu symptoms without causing any drowsiness, and let you have an active day.

Rankof Night Tablets provide relief from cold and flu symptoms along with associated restlessness, hence lets you have a restful night.

 

DOSAGE AND ADMINISTRATION:

Day Tablet:

  • Day Tablet: One tablet, two times a day
  • Do not take a dose in a gap of less than 6 hours
  • Do not exceed the recommended dose
  • Not suitable for children below 12 years of age
  • In case of overdose seek medical advice

 

Night Tablet:

  • Night Tablet: One tablet before going to sleep
  • Do not exceed the recommended dose
  • Not suitable for children below 12 years of age
  • In case of overdose seek medical advice

 

CONTRAINDICATIONS:

Rankof Day and Night Tablets are contraindicated in persons with coronary disease, hypertension, cardiovascular disease, hyperthyroidism, epilepsy and hypersensitivity to any of the ingredients.
It is also contra-indicated in pregnancy and in persons being treated with monoamine oxidase inhibitors or within 10 days of stopping such treatment.

 

PRECAUTIONS AND WARNINGS:

Dosages in excess of those recommended may cause severe liver damage. Do not use continuously for more than 10 days without consulting your doctor.
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.

Paracetamol:
Sensitivity reactions to paracetamol resulting in reversible skin rash or blood disorders may occur, but these are rare. Dosages in excess of those recommended may cause severe liver damage. Patients suffering from liver or kidney disease should take paracetamol under medical supervision.

Caffeine:
Nausea, headache, palpitations and insomnia. Caffeine should be given with care to patients with a history of peptic ulceration.
Phenylephrine:
Hypertension with headache, palpitations, vomiting and reflex bradycardia.
Chlorphenamine Maleate:
Sedation, gastro-intestinal disturbances, headache, blurred vision, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of mouth, tightness of chest and tingling, heaviness and weakness of the hands. Cerebral stimulation, particularly in children, allergy and anaphylaxis may occasionally occur.

INTERACTIONS:

Clinically significant drug interactions may occur on concomitant administration of Rankof Tablets with monoamine oxidase inhibitors, tricyclic antidepressants, beta-adrenergic agents, methyldopa, reserpine and veratrum alkaloids.

 

PREGNANCY AND LACTATION:

Safety of use in pregnancy has not been established.

Known hypersensitivity during breastfeeding.

 

EFFECT TO DRIVE & USE THE MACHINE:

It is advisable not to drive or operate machinery when on treatment with Rankof Day Tablets. Patients should be warned not to drive a motor vehicle, operate dangerous machinery or climb dangerous heights, as impaired decision making could lead to accidents.

 

ADVERSE DRUG REACTIONS:

Adverse Reactions Attributed to Paracetamol

Adverse reactions of paracetamol are rare and usually mild.

Hematologic: Neutropenia and Thrombocytopenia Purpura have been reported and rarely agranulocytosis.

Hypersensitivity: Reactions including skin eruptions, laryngeal edema, bronchospasm, and/or anaphylaxis have occurred rarely. Dose-dependent cross-sensitivity to paracetamol may occur in aspirin-sensitive asthmatics.

Renal: Nephropathy, including papillary renal failure has been reported following consumption of large amounts of paracetamol. Renal tubular necrosis has been associated occasionally with hepatic injury produced by paracetamol overdose.

 

Adverse Reactions Attributed to Caffeine

Caffeine may cause nausea, abdomen abdominal pain, diarrhea, insomnia, restlessness, nervousness, tinnitus, muscular tremor and palpitations.

 

Adverse Reactions Attributed to Phenylephrine

Allergic reaction (difficulty breathing, closing of the throat, swelling of lips, tongue or face or hives), seizures; unusual behavior or hallucinations or an irregular or fast heartbeat.

Other less serious side effects may be more likely to occur: dizziness, lightheadedness or drowsiness, headache, insomnia, anxiety, tremor (shaking) or restlessness, nausea or vomiting or sweating.

 

Adverse Reactions Attributed to Antihistamines, Including, Chlorphenamine Maleate

Central Nervous System: Sedation, extrapyramidal reactions, dizziness, drowsiness, disturbed coordination, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, paresthesias, neuritis, convulsions, euphoria, hallucinations, hysteria, faintness.

Allergic: Peripheral, angioneurotic and laryngeal edema, drug rash, urticaria, photosensitivity, anaphylactic shock.

Gastrointestinal: Epigastric distress, dryness of mouth, anorexia, nausea, vomiting, diarrhea, constipation.

Cardiovascular: Hypotension, headache, palpitations, tachycardia, extrasystoles.

Genitourinary: Urinary frequency, difficult urination, urinary retention, early menses.

Respiratory: Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness, dryness of nose and throat.

 

OVERDOSAGE:

Symptoms of overdosage with paracetamol include nausea and vomiting.
Liver damage which may be fatal may only appear after a few days. Kidney failure has been described following acute intoxication.
Chlorphenamine overdosage may result in excitement, convulsions in susceptible persons and hypotension.
Overdosage of phenylephrine may cause tachycardia. Symptoms of overdosage of caffeine include restlessness, excitement, muscle tremor, tinnitus, scintillating scotoma, tachycardia and extra systoles.
In the event of overdosage, consult a doctor or take the patient to the nearest hospital immediately. Specialized treatment is essential as soon as possible.

 

PRESENTATION: Combipack of 9 (6 Day + 3 Night ) Tablets

STORAGE: Store in a dry place below 30oC. Keep out of reach of children.

 
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