Justeen Pharmaceauticals Limited

COL-COL SYRUP

Diphenhydramine, Guaiphenesin, Bromhexine, Ammonium Chloride & Menthol Syrup

• QUALITATIVE AND QUANTITATIVE COMPOSITION

  Each 5 ml contains:
  Diphenhydramine HCL BP: 8 mg
  Guaiphenesin BP: 50 mg
  Bromhexine HCL BP: 4 mg
  Ammonium Chloride BP: 100 mg
  Menthol BP: I mg
  Flavoured Syrupy Base: Q.S.
  Colour: Carmoisine & Sunset Yellow FCF
  

• PHARMACEUTICAL FORM

  Syrup.
  For oral administration.
  

• CLINICAL PARTICULARS

  Therapeutic indications

  It is indicated in cough & other congestive symptoms, for relief in productive & non productive cough, in cough associated with laryngitis, pharyngitis, chronic bronchitis & pulmonary congestion.

  Posology and method of administration

  5 ml 3-4 times daily; usually to t.i.d.

  In children below 6 years, dose may be 2.5 mI 3-4 times daily; OR as directed by physician.

  Contraindications

  Hypersensitivity

  Special warnings and precautions for use

  WARNINGS
  The use of COL COL syrup leads to drowsiness and impaired concentration which is aggravated by the simultaneous intake of alcohol and it is unsafe to drive a vehicle or be in charge of machinery while using this medicine, as impaired decision making could lead to accidents.

  Precautions

  Guaiphenesin:
  should not be given for persistent cough occurring with smoking, asthma or emphysema, or where excessive secretions accompany cough.

  Bromhexine:
  Use with care in patients with peptic ulceration.

  Others:
  Transient rise in serum aminotransferase.

  Diphenhydramine:
  Epilepsy, elderly, urinary and G.I. obstruction, driving, lactation.

  Interaction with other medicinal products and other forms of interaction

  Diphenhydramine administration significantly reduces the absorption of the antituberculous agent pass from the gastrointestinal tract. CNS depressants may potentiate the sedative action of diphenhydramine. Alcohol potentiates the sedative effects of diphenhydramine. Anticholinergic drugs may potentiate diphenhydramine's anticholinergic side effects.

  Extreme caution should be exercised with patients taking COL-COL in conjunction with nervous system depressants such as alcohol, barbiturates, hypnotics, narcotics analgesic sedatives and tranquillizers and anticholinergic agents and tricyclic antidepressants as their effects may be enhanced by diphenhydramine.

  Monoamine-oxidase inhibitors may enhance the anticholinergic effects of diphenhydramine hydrochloride. The warning signs of damage caused by ototoxic medicines may be masked by diphenhydramine hydrochloride. Guaifenesin may increase renal clearance for urate and thereby lower serum uric acid levels. Guaifenesin may produce an increase in urinary 5-hydroxyindoleacetic acid and may therefore interfere with the interpretation of this test for the diagnosis of carcinoid syndrome. It may also falsely elevate the VMA test for catechols.

  Administration of this drug should be discontinued 48 hours prior to the collection of urine specimens for such tests. Bromhexine has been known to increases the activity of antibiotics, which can have adverse health effects. Ammonium chloride may increase the serum concentration of aluminum acetylsalicylate. Menthol reduces effect of warfarin.

  Pregnancy and lactation

  There are no studies of COL-COL syrup in pregnant women. COL -COL syrup should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus.

  Undesirable effects

  Nausea, vomiting, dizziness, headache and rash. CNS depression, paradoxical stimulation (children), dryness of mouth, thickened respiratory section, blurring of vision, constipation, urinary retention, bradycardia followed by tachycardia and arrhythmias, G.I. disturbances, blood dyscrasias.

  Overdose

  If poisoning or excessive overdosage is suspected it is recommended, on general principles, that vomiting be induced or gastric lavage be performed, and such symptomatic supportive therapy be administered as appears indicated.

• PHARMACOLOGICAL PROPERTIES

  Pharmacodynamic properties

  Diphenhydramine Hel:
  Diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells. Diphenhydramine hydrochloride is widely distributed throughout the body, including the CNS.

  A portion of the drug is excreted unchanged in the urine, while the rest is metabolized via the liver.

  Guaiphenesin
  Guaiphenesin acts centrally by depressing or blocking nerve impulse transmission at the internuncial neuron level of the subcortical areas of the brain, brainstem and spinal cord. It relaxes both the laryngeal and pharyngeal muscles, thus allowing easier intubation. Guaiphenesin also has mild intrinsic analgesic and sedative qualities.

  Bromhexine Hel:
  Bromhexine is an oral mucolytic agent with a low level of associated toxicity. Bromhexine acts on the mucus at the formative stages in the glands, within the mucus-secreting cells. Bromhexine disrupts the structure of acid mucopolysaccharide fibres in mucoid sputum and produces a less viscous mucus, which is easier to expectorate.

  Ammonium chloride:
  The acidification properties of ammonium chloride are caused by its dissociation into chloride and ammonium ions in vivo. The ammonium ion is converted by the liver to urea with the release of a hydrogen ion. This ion combines with bicarbonate to form water and carbon dioxide.

  In the extracellular fluid, chloride ions combine with fixed bases and decrease the alkaline reserves in the body. The net effects are decreased serum bicarbonate levels and a decrease in blood and urine pH.

  Menthol Menthol is an antiseptic, antipruritic, analgesic, and anesthetic, as well as a germicide. It is used for the same purposes as oil of cloves. It is used extensively in headache, being rubbed on the forehead. Owing to its analgesic properties, it is used in the form of an ointment in various strengths for painful hemorrhoids, burns, boils, and superficial inflammations.

  Pharmacokinetic properties

  Diphenhydramine HeI:
  Diphenhydramine Hel is well absorbed from gastro-intestinal tract. Peak plasma concentration are achieved about I to 4 hours after administration by mouth. A mean peak plasma-diphenhydramine concentration of 110 mg per ml has been reported after administration of 50 mg four times daily by mouth.

  Diphenhydramine is widely distributed throughout the body including the CNS. It crosses the placenta and has been detected in breast milk. Diphenhydramine is highly bound to plasma proteins. Metabolism is extensive. Diphenhydramine is excreted mainly in the urine as metabolites. Little is excreted as unchanged drug. Excretion is almost completed within 24 hours of administration.

  Bromhexine HeI:
  Bromhexine Hydrochloride is rapidly absorbed from the gastro-intestinal tract and about 85 to 90% of a dose is excreted in the urine mainly as metabolites. Bromhexine is highly bound to plasma proteins. Administration of bromhexine hydrochloride by mouth to healthy subjects products peak plasma concentrations after about 1 hour. Only small amounts were excreted unchanged in the urine with a half life of about 6.5 hours.

  Guaiphenesin:
  Guaiphenesin is absorbed from the gastro-intestinal tract. It is metabolised and excreted in the urine. Ammonium Chloride: Ammonium Chloride is absorbed from the gastro-intestinal tract. The ammonium ion is converted into urea in the liver, the anion thus liberated into the blood stream and extracellular fluid causes a metabolic acidosis and decreases the pH of the urine; this is followed by transient diuresis.

  Menthol:
  After absorption, menthol is excreted in the urine and bile as a glucuronide.

• PHARMACEUTICAL PARTICULARS

  Special precaution for storage
  Store below 30°C.
  KEEP OUT OF REACH OF CHILDREN