Pretuval

The orange coloured daytime

capsules provide non-drowsy,

temporary relief from the symptoms

of the common cold & flu:

headaches, muscular aches, fever

body aches and pains, sore throat,

stuffy noses and dry irritating

coughs.

The blue coloured nighttime capsules

temporarily relieve the symptoms of

the common cold and flu: minor

aches, pains, headache, muscular

aches, sore throat and fever. It also

relieves dry, irritating coughs due to

minor throat and bronchial irritation,

nasal and sinus congestion, runny

nose, sneezing, itchy, watery eyes,

and sinus pain.

Acetaminophen (Pretuval) is a pain reliever and fever reducer.

Dextromethorphan (Pretuval) is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Pseudoephedrine (Pretuval) is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Pretuval is a combination medicine used to treat headache, fever, body aches, cough, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

Pretuval may also be used for purposes not listed in this medication guide.

Usual Adult Dose for Cold Symptoms

Pretuval 1000 mg-30 mg-60 mg /30 mL oral liquid:

30 mL orally every 6 hours not to exceed 4 doses daily.

Pretuval 325 mg-15 mg-30 mg oral capsule:

2 capsules orally with water every 6 hours not to exceed 8 capsules daily.

Usual Pediatric Dose for Cold Symptoms

Pretuval 1000 mg-30 mg-60 mg /30 mL oral liquid:

12 yrs or older: 30 mL orally every 6 hours not to exceed 4 doses daily.

Pretuval 325 mg-15 mg-30 mg oral capsule:

12 yrs or older: 2 capsules with water every 6 hours not to exceed 8 capsules daily.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

The FDA has not approved use of over-the-counter cough and cold medications to children aged less than 2 years, and proper dosing for children in this age group has not been studied. Clinicians should be aware of the risk for serious illness or fatal overdose from administration of cough and cold medications to children aged less than 2 years. Clinicians should be certain that caregivers understand 1) the importance of administering cough and cold medications only as directed and 2) the risk for overdose if they administer additional medications that might contain the same ingredient.

Dialysis

Data not available

See also:
What is the most important information I should know about Pretuval?

Hypersensitivity to any of the ingredients.

Paracetamol should not be used in patients with severe liver disease.

Do not use this product if you are being treated with monoamine oxidase inhibitors, or within two weeks of stopping treatment with these medications.

Pseudoephedrine (Pretuval) hydrochloride should not be used in patients suffering from any of the following: heart disease (especially coronary insufficiency or arrhythmias), high blood pressure (hypertension), an overactive thyroid gland (hyperthyroidism), tumour of the adrenal gland (phaeochromocytoma), raised intraocular pressure (closed-angle glaucoma) and diabetes mellitus. Pseudoephedrine (Pretuval) hydrochloride should be avoided in patients receiving chloroform, cyclopropane, halothane or other halogenated anaesthetics.

Pregnancy and lactation.

Use Pretuval drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pretuval drops may be taken with or without food.
• Use the dropper that comes with Pretuval drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Pretuval drops, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pretuval drops.

See also:
What other drugs will affect Pretuval?

This product should not be used with the following medications because very serious (rarely fatal) interactions may occur: MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), sibutramine.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication. Avoid taking MAO inhibitors within 2 weeks of starting or stopping this medication.

Before using this product, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: antispasmodics (e.g., atropine, belladonna alkaloids), beta blockers (e.g., metoprolol, atenolol), drugs for Parkinson’s disease (e.g., anticholinergics such as benztropine, trihexyphenidyl), guanethidine, certain inhaled anesthetics (e.g., halothane), memantine, methyldopa, reserpine, scopolamine, tricyclic antidepressants (e.g., amitriptyline, desipramine).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could affect your heart rate/blood pressure or cause drowsiness. Ask your pharmacist about the safe use of those products.

See also:
What are the possible side effects of Pretuval?

Paracetamol may cause pancreatitis, allergic reactions in the form of a rash or blood disorders (including neutropenia, pancytopenia, leucopenia, agranulocytosis and thrombocytopenia). These should disappear on stopping the treatment. The rash usually appears as red areas or allergic wheals, and may be accompanied by fever and involvement of the mucous membranes.

The most common side-effect due to chlorpheniramine is sedation varying from slight drowsiness to deep sleep, including lassitude, dizziness, and inco-ordination. Paradoxical central nervous system stimulation may occur especially in children, with insomnia, nervousness, euphoria, irritability, tremors, and less frequently, nightmares, hallucinations, and convulsions.

Other side effects may include dry mouth; thickened respiratory tract secretions and tightness of the chest, blurred vision, urinary difficulty and retention, constipation and increased gastric reflux. In addition, gastro-intestinal disturbances may occur such as nausea, vomiting, diarrhoea or epigastric pain.

Hypersensitivity reactions may occur. Blood disorders including agranulocytosis, leucopenia, haemolytic anaemia and thrombocytopenia, have been reported. Other less frequently reported side-effects include hypotension, tinnitus, headache and paraesthesias.

Chloropheniramine should be given with care to patients with glaucoma, urinary retention, prostatic hypertrophy or pyloroduodenal obstruction. Caution is advised in patients with epilepsy and severe cardiovascular disorders.

Chlorpheniramine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotic, analgesics, sedatives and tranquillisers. Care should be taken when taking medicines containing tricyclic anti-depressants or atropine together.

Elderly patients are more susceptible to the central nervous system depressant and lowering of blood pressure effects even at dose quantities effective for treatment.

The warning signs of damage caused by ototoxic medicines may be masked by chlorpheniramine.

Other central nervous system depressants, such as alcohol, barbiturates, hyponotics, narcotic analgesics, sedatives and tranquillisers, if taken together will increase the chance of sedation. Be careful when taking medicines containing tricyclic anti-depressants or atropine together.

Pseudoephedrine (Pretuval) hydrochloride may cause giddiness, headache, nausea, vomiting, sweating, thirst, rapid or irregular heart beat (tachycardia, ventricular arrhythmia), pain in front of the heart (precordial pain), palpitations, raised blood pressure (hypertension), micturition, difficulty in urination, muscular weakness, tremors, anxiety, restlessness and inability to sleep, fear, confusion, psychotic states, reduced appetite, dyspnoea, sweating, hypersalivation, altered metabolism including disturbance in glucose metabolism. Tolerance with dependence may occur after continued use.

The effects of Pseudoephedrine (Pretuval) hydrochloride are lessened by medicines containing guanethidine, reserpine, methyldopa and may be diminished or enhanced by tricyclic antidepressants. It may increase the possibility of irregular heart beat in patients taking digitalis.

Pseudoephedrine (Pretuval) may increase blood pressure and therefore special care is advisable in patients receiving antihypertensive therapy.