Pseudoephedrine hydrochloride and Triprolidine hydrochloride Tablets 30mg/2.5mg Taj Pharma

Pseudoephedrine hydrochloride and Triprolidine hydrochloride Tablets 30mg/2.5mg

  1. Name of the medicinal product

Pseudoephedrine hydrochloride and Triprolidine hydrochloride Tablets 30mg/2.5mg, 60mg/2.5mg Taj Pharma

  1. Qualitative and quantitative composition

Each tablet contains:-
Pseudoephedrine hydrochloride 30.0 mg
Triprolidine hydrochloride 2.5 mg

Each tablet contains:-
Pseudoephedrine hydrochloride 60.0 mg
Triprolidine hydrochloride 2.5 mg

  1. Pharmaceutical form

Tablets for oral administration.

  1. Clinical particulars

4.1 Therapeutic indications

For the symptomatic relief of upper respiratory tract disorders which are benefited by a combination of a nasal decongestant and histamine H1-receptor antagonist, for example:

Allergic Rhinitis

Vasomotor Rhinitis

The Common Cold and Influenza

4.2 Posology and method of administration

Adults and children over 12 years

One tablet every 4-6 hours up to 4 times a day

Use in the Elderly

No specific studies have been carried out in the elderly, but triprolidine and pseudoephedrine have been widely used in older people.

Hepatic Dysfunction

Caution should be exercised when administering Pseudoephedrine hydrochloride and Triprolidine hydrochloride Tablets to patients with severe hepatic impairment.

Renal Dysfunction

Caution should be exercised when administering Pseudoephedrine hydrochloride and Triprolidine hydrochloride Tablets to patients with moderate to severe renal impairment.

4.3 Contraindications

Pseudoephedrine hydrochloride and Triprolidine hydrochloride is contraindicated in individuals who have previously exhibited intolerance to it or to pseudoephedrine or triprolidine.

Pseudoephedrine hydrochloride and Triprolidine hydrochloride is contraindicated in patients 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.

Pseudoephedrine hydrochloride and Triprolidine hydrochloride is contraindicated in patients with severe hypertension or severe coronary artery disease.

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 Pseudoephedrine hydrochloride and Triprolidine hydrochloride Tablets and furazolidone they should not be taken together.

4.4 Special warnings and precautions for use

Pseudoephedrine hydrochloride and Triprolidine hydrochloride Tablets 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 Pseudoephedrine hydrochloride and Triprolidine hydrochloride Tablets should avoid the concomitant use of alcohol or other centrally acting sedatives.

Although pseudoephedrine has virtually no pressor effect in normotensive patients, Pseudoephedrine hydrochloride and Triprolidine hydrochloride Tablets should be used with caution in patients taking anti-hypertensive agents, tricyclic antidepressants or other sympathomimetic agents, such as decongestants, appetite suppressants and amfetamine-like psychostimulants. The effects of a single dose of Pseudoephedrine hydrochloride and Triprolidine hydrochloride Tablets on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment.

As with other sympathomimetic agents Pseudoephedrine hydrochloride and Triprolidine hydrochloride Tablets should be used with caution in patients with hypertension, heart disease, diabetes, hyperthyroidism, elevated intraocular pressure and prostatic enlargement.

There have been no specific studies of Pseudoephedrine hydrochloride and Triprolidine hydrochloride Tablets in patients with hepatic and/or renal dysfunction. Caution should be exercised in the presence of severe renal or hepatic impairment.

There is insufficient information available to determine whether triprolidine or pseudoephedrine have mutagenic or carcinogenic potential.

Systemic administration of pseudoephedrine in rats, up to 7 times the human daily dosage in females and 35 times the human daily dosage in males, did not impair fertility nor alter foetal morphological development and survival.

No studies have been conducted in animals to determine if triprolidine has the potential to impair fertility.

There is no information on the effects of Pseudoephedrine hydrochloride and Triprolidine hydrochloride on human fertility.

The packs carry the following statements:-

Store below 25oC

Keep dry

Protect from light

Keep out of the reach of children

Warnings, may cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.

The 12 tablet pack carries the additional statements:-

If symptoms persist consult your doctor.

Do not exceed the stated dose.

As with all medicines if you are pregnant, or currently taking any other medicine, consult your doctor or pharmacist before taking this product.

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant use of Pseudoephedrine hydrochloride and Triprolidine hydrochloride Tablets with sympathomimetic agents, such as decongestants, tricyclic antidepressants, appetite suppressants and amfetamine-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, Pseudoephedrine hydrochloride and Triprolidine hydrochloride 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.

4.6 Pregnancy and lactation

Although pseudoephedrine, and triprolidine 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.

Systemic administration of triprolidine in rats and rabbits up to 75 times the human dose 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.

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 approximately 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.

4.7 Effects on ability to drive and use machines

Pseudoephedrine hydrochloride and Triprolidine hydrochloride 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.

4.8 Undesirable effects

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 men receiving pseudoephedrine; prostatic enlargement could have been an important predisposing factor.

4.9 Overdose

The effects of acute toxicity from Pseudoephedrine hydrochloride and Triprolidine hydrochloride may include drowsiness, lethargy, dizziness, ataxia, weakness, hypotonicity, respiratory depression, dryness of the skin and mucous membranes, tachycardia, hypertension, hyperpyrexia, hyperactivity, irritability, convulsions, and difficulty with micturition.

Necessary measures should be taken to maintain and support respiration and control convulsions. Gastric lavage should be performed up to 3 hours after ingestion if indicated. Catheterisation of the bladder may be necessary. If desired, the elimination of pseudoephedrine can be accelerated by acid diuresis or by dialysis.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Triprolidine provides symptomatic relief in conditions believed to depend wholly or partly 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 direct and indirect sympathomimetic activity and is an effective upper respiratory tract 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.

After oral administration of a single dose of 2.5mg 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.

5.2 Pharmacokinetic properties

After the administration of one Pseudoephedrine hydrochloride and Triprolidine hydrochloride Tablet (containing 2.5 mg triprolidine hydrochloride and 60 mg pseudoephedrine hydrochloride) in healthy adult volunteers, the peak plasma concentration (Cmax) of triprolidine is approximately 5.5 ng/ml – 6.0 ng/nl, occurring at about 2.0 hours (Tmax) after drug administration. The plasma half life of triprolidine is approximately 3.2 hours. The Cmax of pseudoephedrine is approximately 180 ng/ml with Tmax approximately 2.0 hours after drug administration. The plasma half life of pseudoephedrine 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.

5.3 Preclinical safety data

There is insufficient information available to determine whether Triprolidine pseudoephedrine have mutagenic or carcinogenic potential.

Systematic administration of pseudoephedrine in rats, up to 7 times the human daily dosage in females and 35 times the human daily dosage in males, did not impair fertility nor alter foetal morphological development and survival.

No studies have been conducted in animal to determine if Triprolidine has the potential to impair fertility.

Systemic administration of Triprolidine in rats and rabbits up to 75 times the human dose 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.

  1. Pharmaceutical particulars

6.1 List of excipients

Lactose, Maize starch, Povidone, Magnesium stearate

6.2 Incompatibilities

None known

6.3 Shelf life

36 months

6.4 Special precautions for storage

Store below 25°C

Store in original package to protect from light and moisture

6.5 Nature and contents of container

12 tablets in pvc/pvdc/aluminium foil blister packs.

6.6 Special precautions for disposal and other handling

None

Administrative data

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com

 

Pseudoephedrine hydrochloride and Triprolidine hydrochloride Tablets 30mg/2.5mg, 60mg/2.5mg Taj Pharma

 

This medicine is used to relieve the symptoms of colds, flu and allergies including runny nose, watery eyes, nasal congestion and blocked sinuses.

This medicine is for use by adults and children aged 12 years and over.

 

Do not use this medicine:

  • There are some people who should not use this medicine. To find out if you are one of them See Section 2 c
  • If you have ever had a bad reaction to any of the ingredients. For the list of ingredients See Section 6 c

Speak to your doctor:

  • If you suffer from any of the conditions mentioned in Section 2. See Section 2 c
  • If you are taking any other medicines. See Section 2 c

Follow the dosage instructions carefully. See Section 3 c

Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you might need it again.

  1. What the medicine is for

Pseudoephedrine hydrochloride and Triprolidine hydrochloride Tablets is a medicine which is used to relieve the symptoms of colds, flu and allergies including sneezing, runny nose, watery eyes, nasal congestion and blocked sinuses. The tablets contain pseudoephedrine hydrochloride, which is a decongestant that relieves nasal and sinus congestion and triprolidine hydrochloride which is an antihistamine that helps stop sneezing, runny nose and watery eyes.

This medicine is for use in adults and children aged over 12 years.

  1. Before taking this medicine

This medicine is suitable for most adults and children aged over 12 years but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.

Do not take this medicine…

  • If you have very high blood pressure or
  • severe heart
  • If you have ever had a bad reaction to any of the ingredients.
  • If you are taking, or have taken in the last two weeks, drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs).
  • If you are taking furazolidone (an antibacterial
  • agent).

If any of these apply to you, get advice from a doctor or pharmacist without taking Pseudoephedrine hydrochloride and Triprolidine hydrochloride Tablets. 

Talk to your doctor or pharmacist…

  • If you have liver or kidney
  • If you have high blood pressure or heart disease.
  • If you have diabetes or if you been told by your doctor that you have an intolerance to some
  • If you have an overactive thyroid gland.
  • If you have glaucoma (increased pressure in the eye).
  • If you have prostate problems (difficulty with passing water or needing to pass water often).
  • If you are taking
  • If you are taking any other medicines, including:
  • Sedatives (drugs used to treat anxiety and
  • tension).
  • Antihypertensives (drugs used to treat high blood pressure such as guanethidine, methyldopa, alpha and beta blockers, debrisoquine, bretylium and betanidine).
  • Sympathomimetic drugs (stimulants or appetite suppressants and drugs used to treat congestion and asthma).
  • Tricyclic antidepressants (used to treat mood disorders).

If you are not sure about any of the medicines you are taking, show the bottle or pack to your pharmacist.

If any of these bullet points apply to you now or in the past, talk to a doctor or pharmacist.

If you are pregnant or breast-feeding

  • Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breast-feeding.

Special warnings about this medicine

  • This medicine may cause drowsiness. If affected, do not drive or operate machinery. Avoid alcoholic drink.

Some of the ingredients can cause problems

  • This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this
  1. How to take this medicine

Check the tables below to see how much medicine to take.

  • For oral use
  • Do not use more than the stated dose shown in the

Children aged 12 years or under

This medicine is not recommended for children aged 12 years or under.

If anyone has too much

If anyone has taken too many tablets contact a doctor or your nearest Accident and Emergency Department (Casualty) taking this leaflet and pack with you.

If you forget to take the medicine

If you forget to take a dose, take the next dose when needed provided that the last dose was taken at least 4 hours ago. Do not take a double dose.

  1. Possible side-effects

Pseudoephedrine hydrochloride and Triprolidine hydrochloride Tablets can have side-effects, like all medicines, although these don’t affect everyone and are usually mild.

If you experience any of the following, stop using this medicine and talk to your doctor:

  • A few people have had hallucinations, but this is
  • Occasionally people get skin rashes that are sometimes
  • A few people may find their heartbeat
  • A few men, especially men with prostate problems, may have trouble passing water.

Other effects which may occur include:

  • Restlessness, having trouble getting to sleep or bad dreams.
  • Dry mouth, nose or

If you experience any side-effects not included in this leaflet or are not sure about anything, talk to your doctor or pharmacist.

  1. Storing this medicine

Store below 25°C.

Store in the original package to protect from light and moisture.

Keep the product out of the reach and sight of children.

Do not use after the end of the month shown as an expiry date on the packaging.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment

  1. Further information

What’s in this medicine?

The active ingredients in Pseudoephedrine hydrochloride and Triprolidine hydrochloride

Tablets are: Pseudoephedrine hydrochloride 30mg, 60 mg and triprolidine hydrochloride 2.5 mg in each tablet.

Other ingredients are: Lactose, maize starch, povidone and magnesium stearate.

What the medicine looks like

Pseudoephedrine hydrochloride and Triprolidine hydrochloride Tablets are white tablets available in packs of 12.

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com

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