UNIFED^® DM is indicated for the symptomatic relief of upper respiratory tract disorders which are benefited by the combination of a nasal decongestant, a histamine H₁-receptor antagonist, and an antitussive.

Route of administration: Orally.

Adults and children aged 12 years and over:

10 ml every 4 -6 hours up to four times a day

Children under 12 years:

UNIFED^® DM is contraindicated in children under the age of 12 years

The Elderly:

There have been no specific studies of UNIFED^® DM in the elderly. Experience has indicated that normal adult dosage is appropriate.

Hepatic dysfunction:

Caution should be exercised when administering UNIFED^® DM to patients with severe hepatic impairment.

Renal dysfunction:

Caution should be exercised when administering UNIFED^® DM to patients with moderate to severe renal impairment.

UNIFED® DM is contraindicated in individuals who have previously exhibited intolerance to it or to any of its constituents. UNIFED® DM is contraindicated in patients with severe hypertension or severe coronary artery disease. UNIFED® DM is contraindicated in individuals who are taking, or have taken, monoamine oxidase inhibitors within the preceding two weeks. The concomitant use of pseudoephedrine and this type of product may occasionally cause a rise in blood pressure. The antibacterial agent, furazolidone, is known to cause a dose-related inhibition of monoamine oxidase. Although there are no reports of hypertensive crises caused by the concurrent administration of UNIFED® DM and furazolidone they should not be taken together. UNIFED® DM should not be administered to patients where cough is associated with asthma or where cough is accompanied by excessive secretions. Dextromethorphan, in common with other centrally acting antitussive agents, should not be given to patients in, or at risk of developing respiratory failure. Children under 12 years old: should not be used.

UNIFED^® DM may cause drowsiness, and impair performance in tests of auditory vigilance. Patients should not drive or operate machinery until they have determined their own response.

Although there are no objective data, users of UNIFED^® DM should avoid the concomitant use of alcohol or other centrally acting sedatives.

Although pseudoephedrine has virtually no pressor effects in patients with normal blood pressure, UNIFED^® DM should be used with caution in patients taking antihypertensive agents, tricyclic antidepressants, other sympathomimetic agents such as decongestants, appetite suppressants and amfetamine-like psychostimulants. The effects of a single dose of UNIFED^® DM on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment.

As with other sympathomimetic agents, caution should be exercised in patients with hypertension, heart disease, diabetes, hyperthyroidism, elevated intra-ocular pressure or prostatic enlargement.

There have been no specific studies of UNIFED^® DM in patients with hepatic and/or renal dysfunction UNIFED^® DM should be used with caution in patients with liver disease.

There have been a few reports of abuse of dextromethorphan but there is no evidence of drug dependence at therapeutic dosages.

Not more than 4 doses should be given in any 24 hours.

Do not exceed the stated dose.

The packs carry the following statements

Warning: May cause drowsiness. If affected do not operate machinery.

This medicine can make you feel sleepy. Do not drive while taking this medicine until you know how it makes you feel.

Avoid alcoholic drink.

If you are pregnant or currently taking any other medicine, consult your doctor or pharmacist before taking this product.

If symptoms persist consult your doctor.

Concomitant use of UNIFED^® DM with sympathomimetic agents such as decongestants, tricyclic antidepressants, appetite suppressants and amphetamine-like psychostimulants or with monoamine oxidase inhibitors, which interfere with the catabolism of sympathomimetic amines, may occasionally cause a rise in blood pressure, Because of its pseudoephedrine content, UNIFED^® DM may partially reverse the hypotensive action of drugs which interfere with sympathetic activity including bretylium, betanidine, guanethidine, debrisoquine, methyldopa, alpha- and beta- adrenergic blocking agents

 

Although pseudoephedrine, triprolidine and dextromethorphan have been in widespread use for many years without apparent ill consequence, there are no specific data on their use during pregnancy. Caution should therefore be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing foetus.

Pseudoephedrine and triprolidine are excreted in breast milk in small amounts but the effect of this on breast-fed infants is not known. It has been estimated that 0.5 to 0.7% of a single dose of pseudoephedrine ingested by a mother will be excreted in the breast milk over 24 hours.

It is not known whether dextromethorphan or its metabolites are excreted in breast milk.

No studies have been conducted in animals to determine whether triprolidine, pseudoephedrine or dextromethorphan have potential to impair fertility. There is no experience of the effect of UNIFED^® DM on human fertility.

In rats and rabbits, systemic administration of triprolidine up to 75 times the human daily dosage did not produce teratogenic effects.

Systemic administration of pseudoephedrine, up to 50 times the human daily dosage in rats and up to 35 times the human daily dosage in rabbits, did not produce teratogenic effects.

There is insufficient information available to determine whether dextromethorphan has teratogenic potential.

Triprolidine may cause drowsiness and patients should not drive or operate machinery until they have determined their own response.

This medicine can impair cognitive function and can affect a patient's ability to drive safely. When taking this medicine, patients should be told:

-       The medicine is likely to affect your ability to drive

-       Do not drive until you know how the medicine affects you

-       It is an offence to drive while under the influence of this medicine

-       However, you would not be committing an offence (called 'statutory defence') if:

·       The medicine has been taken to treat a medical or dental problem and

·       You have taken it according to the information provided with the medicine with the medicine and

·       It was not affecting your ability to drive safely.

Central nervous system depression or excitation may occur, drowsiness being reported most frequently. Sleep disturbance and rarely, hallucinations have been reported.

Skin rashes, with or without irritation, tachycardia, dryness of mouth nose and throat have occasionally been reported. Urinary retention has been reported occasionally in male patients in whom prostatic enlargement could be an important predisposing factor.

Side effects attributed to dextromethorphan are uncommon; occasionally nausea, vomiting or gastro-intestinal disturbance may occur.

 

To report any side effect(s):

·     Saudi Arabia:

-     National Pharmacovigilance & Drug Safety Centre (NPC): ·     Fax: +966-11-205-7662 ·     Call NPC at +966-11-2038222, Ext.: 2317-2356-2353-2354-2334-2340. ·     Toll free phone : 8002490000 ·     E-mail: npc.drug@sfda.gov.sa ·     Website: www.sfda.gov.sa/npc

-   Other GCC States:

Please contact the relevant competent authority.

 

Signs and symptoms:

The signs of acute toxicity from UNIFED^® DM may include drowsiness, lethargy, dizziness, ataxia, weakness, hypotonicity, respiratory depression, dryness of the skin and mucous membranes, tachycardia, hypertension, hyperpyrexia, hyperactivity, irritability, convulsions, difficulty with micturition, nausea and vomiting.

Treatment:

Necessary measures should be taken to maintain and support respiration and control convulsions. Gastric lavage may be undertaken if indicated. Catheterisation of the bladder may be necessary. If desired, the elimination of pseudoephedrine can be accelerated by acid diuresis or by dialysis.

Naloxone has been used successfully as a specific antagonist to dextromethorphan toxicity in children.

ATC code: ROIBA52

Triprolidine provides symptomatic relief in conditions believed to depend wholly or partially upon the triggered release of histamine. It is a potent competitive histamine H₁-receptor antagonist of the pyrrolidine class with mild central nervous system depressant properties which may cause drowsiness. Pseudoephedrine has a direct and indirect sympathomimetic activity and is an effective upper respiratory decongestant. Pseudoephedrine is substantially less potent than ephedrine in producing both tachycardia and elevation of systolic blood pressure and considerably less potent in causing stimulation of the central nervous system. Dextromethorphan has an antitussive action. It controls coughs by depressing the medullary cough centre.

After oral administration of a single dose of 2.5 mg triprolidine to adults, the onset of action as determined by the ability to antagonise histamine-induced weals and flares in the skin is within 1 to 2 hours. Peak effects occur at about 3 hours and, although activity declines thereafter, significant inhibition of histamine-induced weals and flares still occurs 8 hours after the dose. Pseudoephedrine produces its decongestant effect within 30 minutes, persisting for at least 4 hours.

A single oral dose of 10 - 20 mg dextromethorphan produces its antitussive action within 1 hour and lasts for at least 4 hours.

 

After the administration of 2.5 mg triprolidine hydrochloride and 60 mg pseudoephedrine hydrochloride to healthy adult volunteers, the peak plasma concentration (C_max) of triprolidine is approximately 5.5 ng/ml - 6.0 ng/ml occurring at about 1.5 - 2.0 hours (T_max) after drug administration. Its plasma half-life is approximately 3.2 hours. The C_max of pseudoephedrine is approximately 180 ng/ml with T_max approximately 1.5 - 2.0 hours after drug administration. The plasma half-life is approximately 5.5 hours (urine pH maintained between 5.0 - 7.0). The plasma half-life of pseudoephedrine is markedly decreased by acidification of urine and increased by alkalinisation. Genetically controlled O-demethylation is the main determinant of dextromethorphan pharmacokinetics in human volunteers. It appears that there are two distinct phenotypes for this oxidation process resulting in highly variable pharmacokinetics between subjects.

Not Applicable.

-       Sorbitol Solution

-       Sucrose

-       Sodium Bonzoate

-       Methylparaben

-       Glycerin

-       Sodium Saccharine

-       Hydroxy Ethyl Cellulose

-       Usacert FD&C Yellow No.6

-       Flavors

-       Purified Water

Not Applicable.

2 Years

       Do not store above 30°C.

      Protect from light.

      Discard the content after one month from first opening.

      Do not refrigerate or freeze

-       Bottle: amber glass type III soda-lime glass, intended for pharmaceutical uses.

-       Cap: white, cylindrical, polypropylene inner and outer caps, LD polyethylene ring and insert, child resistant.

-       Adhesive label.

-       Outer box.

-       Multi folded leaflet

Pack Size:

120 ml syrup.

Any unused product or waste should be disposed of in accordance with local requirements.