post-title portfolio-title Hydroxyzine HCl 25mg Tablets USP Taj Pharma 2020-01-20 08:49:52 no no

Hydroxyzine HCl 25mg Tablets USP Taj Pharma

  1. Name of the medicinal product

Hydroxyzine HCl 10mg Tablets USP Taj Pharma
Hydroxyzine HCl 25mg Tablets USP Taj Pharma
Hydroxyzine HCl 50mg Tablets USP Taj Pharma

  1. Qualitative and quantitative composition

a) Each Film Coated Tablet Contains:
Hydroxyzine Hydrochloride USP? ? 10mg
Excipients? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? q.s

b) Each Film Coated Tablet Contains:
Hydroxyzine Hydrochloride USP? ? 25mg
Excipients? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? q.s

c) Each Film Coated Tablet Contains:
Hydroxyzine Hydrochloride USP? ?50mg
Excipients? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? q.s

For the full list of excipients, see section 6.1

  1. Pharmaceutical form

Film-coated tablets

  1. Clinical particulars

4.1 Therapeutic indications

Hydroxyzine Hydrochloride? is indicated to assist in the management of anxiety in adults.

Hydroxyzine Hydrochloride? is indicated for the management of pruritus associated with acute and chronic urticaria, including cholinergic and physical types, and atopic and contact dermatitis in adults and children.

4.2 Posology and method of administration

Posology

Hydroxyzine Hydrochloride? should be used at the lowest effective dose and for the shortest possible duration.

In adults and children over 40 kg in weight, the maximum daily dose is 100 mg per day.

Anxiety

Adults?50-100mg daily in divided doses

Pruritus

Adults?Starting dose of 25mg at night increasing as necessary to 25mg three or four times daily.

Elderly

In the elderly, the maximum daily dose is 50 mg per day (see section 4.4). A reduced dose is advised. This is due to a possible increase in the volume of distribution, prolonged action and the possible effect of age-related changes on pharmacologic functions, including hepatic metabolism and renal excretion (see Section 5.2 ‘Pharmacokinetic properties’)

Paediatric Population

In children up to 40 kg in weight, the maximum daily dose is 2 mg/kg/day.

From 6 months to 6 years, 5-15mg daily in divided doses adjusted depending on the child’s weight.

In children and adolescents over 40 kg in weight the maximum daily dose is 100mg per day.

For children over 6 years, starting at 15-25mg and increasing to 50-100mg daily in divided doses adjusted according to the child’s weight.

As with all medications, the dosage should be adjusted according to the patient’s response to therapy.

Hepatic impairment

The total daily dose should be reduced by 33%. Use in patients with severe liver disease should be avoided (see Section 4.4 ‘Special Warnings and Precautions for Use’)

Renal impairment

For patients with moderate or severe renal impairment, it is recommended that the total daily dosage should be reduced by 50% (see Section 4.4 ‘Special Warnings and Precautions for Use’).

Method of administration: oral.

4.3 Contraindications

Hydroxyzine Hydrochloride? is contra-indicated in the following:

  • patients who have shown previous hypersensitivity to hydroxyzine hydrochloride, cetirizine, other piperazine derivatives, aminophylline or ethylenediamine, or any of the excipients of Hydroxyzine Hydrochloride (for a full list of excipients see section 6.1 ‘List of excipients’)
  • Patients with a known acquired or congenital QT interval prolongation.
  • Patients with a known risk factor to QT interval prolongation including a known cardiovascular disease, significant electrolytes imbalance (hypokalaemia, hypomagnesaemia), family history of sudden cardiac death, significant bradycardia, concomitant use with drugs known to prolong the QT interval and/or induce Torsade de Pointes (see sections 4.4 and 4.5).
  • asthmatics who have previously experienced a serious anti-histamine-induced adverse bronchopulmonary effect
  • porphyria
  • pregnancy and breast-feeding (see section 4.6 ‘Fertility, pregnancy and lactation’)

Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactosemalabsorption should not take this medicine.

4.4 Special warnings and precautions for use

Cardiovascular effects

Hydroxyzine has been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been cases of QT interval prolongation and torsade de pointes in patients taking hydroxyzine. Most of these patients had other risk factors, electrolyte abnormalities and concomitant treatment that may have been contributory (see section 4.8).

Hydroxyzine should be used at the lowest effective dose and for the shortest possible duration.

Treatment with hydroxyzine should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and the patients should seek immediate medical attention.

Patients should be advised to promptly report any cardiac symptoms.

Patients with hepatic impairment

Due to its sedative properties, use of hydroxyzine should be avoided in severe liver disease due to an increased risk of coma, and in patients with hepatic failure due to possibility of hepatic encephalopathy.

Hydroxyzine elimination is impaired in patients with hepatic dysfunction secondary to primary biliary cirrhosis. Dosage should be modified for patients with hepatic impairment (see Section 4.2 ‘Posology and Method of Administration’)

Patients with renal impairment

Hydroxyzine Hydrochloride? should be used with caution in patients with impaired renal function (see Section 4.2 ‘Posology and Method of Administration’). It is uncertain whether the drug may accumulate or have other adverse effects in such patients. Hydroxyzine Hydrochloride? is completely metabolised and one of the metabolites is the active metabolite cetirizine. Cetirizine is renally excreted and clearance is reduced in patients with moderate renal impairment and on dialysis compared to normal volunteers.

Elderly patients

Hydroxyzine is not recommended in elderly patients because of a decrease of hydroxyzine elimination in this population as compared to adults and the greater risk of adverse reactions (e.g. anticholinergic effects) (see sections 4.2 and 4.8). In elderly patients, it is recommended to reduce the dose of hydroxyzine due to a possible increase in the volume of distribution, prolonged action, and the possible effect of age-related changes on pharmacologic functions, including hepatic metabolism and renal excretion (see Section 4.2 ‘Posology and Method of Administration’ and Section 5.2 ‘Pharmacokinetic properties’)

Because of its potential antimuscarinic actions, Hydroxyzine Hydrochloride? should be used with caution in patients suffering from angle-closure glaucoma, urinary retention, prostatic hyperplasia, or pyroduodenal obstruction.

Caution is required in patients suffering the following conditions:

  • seizure disorders including epilepsy
  • myasthenia gravis
  • dementia
  • decreased GI motility
  • bladder outflow obstruction
  • stenosing peptic ulcer
  • patients with breathing problems (e.g. emphysema, chronic bronchitis)
  • increased intraocular pressure
  • hyperthyroidism
  • cardiovascular disease
  • hypertension

Dosage adjustments may be required if Hydroxyzine Hydrochloride? is used simultaneously with other CNS depressants or with drugs having antimuscarinic properties (see section 4.5 ‘Interaction with other medicinal products and other forms of interaction’).

The concomitant use of alcohol and hydroxyzine should be avoided (see section 4.5 ‘Interaction with other medicinal products and other forms of interaction’).

Treatment should be stopped for one week before skin testing for allergy is undertaken, and for 96 hours prior to a methocholine test.

Children and the elderly are more susceptible to side-effects.

Patients should be warned of impaired judgement and dexterity.

4.5 Interaction with other medicinal products and other forms of interaction

Associations contraindicated

Co-administration of hydroxyzine with drugs known to prolong the QT interval and/or induce Torsade de Pointes e.g. class IA (e.g. quinidine, disopyramide) and III antiarrhythmics (e.g. amiodarone, sotalol), some antihistamines, some antipsychotics (e.g. haloperidol), some antidepressants (e.g. citalopram, escitalopram), some antimalarial drugs (e.g. mefloquine), some antibiotics (e.g. erythromycin, levofloxacin, moxifloxacin), some antifungal agents (e.g. pentamidine), some gastro-intestinal medicines (e.g. prucalopride), some medicines used in cancer (e.g., toremifene, vandetanib), methadone, increase the risk of cardiac arrhythmia. Therefore, the combination is contra-indicated (see section 4.3).

Associations requiring precaution of use

Caution with bradycardia and hypokalaemia-inducing drugs.

Hydroxyzine is metabolized by alcohol dehydrogenase and CYP3A4/5 and an increase in hydroxyzine blood concentrations may be expected when hydroxyzine is co-administered with drugs known to be potent inhibitors of these enzymes.

Hydroxyzine Hydrochloride? may also have the following interactions:

Methocholine test Treatment should be stopped for 96 hours prior to a methocholine test, to avoid effects on the test results (see section 4.4 ‘Special warnings and precautions for use’)
Skin testing for allergy Treatment should be stopped at least one week before skin testing for allergy to avoid effects on the test results (see section 4.4 ‘Special warnings and precautions for use’)
CNS depressants Patients should be warned that Hydroxyzine Hydrochloride? may enhance their response to alcohol, barbiturates, benzodiazepines, hypnotics, opioids, anxiolytics, antipsychotics, antidepressents, antiemetics, antiepileptics, other antihistamines, skeletal muscle relaxants, sedatives, anaesthetics and other CNS depressants (see section 4.4 ‘Special warnings and precautions for use’)
Antimuscarinics Antimuscarinic side effects (both peripheral and central) may be increased if Hydroxyzine Hydrochloride? is given with antimuscarinics such as atropine and some antidepressants (both tricyclics and MAOIs) (see section 4.4 ‘Special warnings and precautions for use’)
Adrenaline Hydroxyzine has been shown to inhibit and reverse the vasopressor effect of adrenaline (see Section 4.9 ‘Overdose’)
Anticholinergic agents Additive anticholinergic effects may occur if hydroxyzine is administered concomitantly with other anticholinergic agents
Anticholinesterase drugs Hydroxyzine may antagonise the effects of anticholinesterase drugs
Betahistine Hydroxyzine may antagonise the effects of betahistine
Cimetidine Cimetidine, 600mg twice a day, has been shown to increase the serum concentrations of hydroxyzine and to decrease peak concentrations of the metabolite cetirizine
CYP2D6 & cytochrome P450 Hydroxyzine is an inhibitor of CYP2D6 and may cause drug-drug interactions with CYP2D6 substrates. Cetirizine does not interact with other drug substances via cytochrome P450
Drugs which have effects on the brain Drugs which have effects on the brain will interact with antihistamines
Drugs that affect the hepatic microsomal enzyme system Metabolism may be reduced in patients concomitantly receiving drugs that affect the hepatic microsomal enzyme system. Decreased metabolism may result in accumulation of potentially toxic concentrations of unchanged antihistamine
Ototoxic drugs It has been suggested that some sedating antihistamines could mask the warning signs of damage caused by ototoxic drugs such as aminoglycoside antibiotics
Porter-Silber reaction or the Glenn-Nelson method Hydroxyzine has been reported to cause falsely elevated urinary concentrations of 17-hydroxycorticosteroids when the Porter-Silber reaction or the Glenn-Nelson method is used

4.6 Fertility, pregnancy and lactation

Pregnancy

Hydroxyzine Hydrochloride? should not be used during pregnancy (see section 4.3 ‘Contraindications’).

Clinical data in humans are inadequate to establish safety in early pregnancy.

The use of sedating antihistamines in the latter part of the third trimester may cause adverse effects in neonates such as irritability, paradoxical excitability, and tremor.

Animal studies have shown reproductive toxicity. Foetal abnormalities have been reported when hydroxyzine was administered, at doses substantially above the human therapeutic dose, to the pregnant mouse, rat and rabbit.

Hydroxyzine crosses the placental barrier which may lead to higher foetal than maternal concentrations.

The following events were observed in a neonate whose mother received high dose (600mg per day) hydroxyzine during pregnancy; hypotonia, movement disorders including extrapyramidal disorders, clonic movements, tachypnea and poor feeding.

Lactation

It is expected that Hydroxyzine Hydrochloride? may be excreted into breast milk. The effects on the nursing infant are unknown. Hydroxyzine Hydrochloride? should not be given to nursing mothers (see section 4.3 ‘Contraindications’).

4.7 Effects on ability to drive and use machines

Patients should be warned that Hydroxyzine Hydrochloride? may impair their ability to perform activities requiring mental alertness or physical co-ordination such as operating machinery or driving a vehicle. Concomitant use of hydroxyzine with alcohol or other CNS depressants should be avoided as this may aggravate these effects (see section 4.5 ‘Interaction with other medicinal products and other forms of interaction).

4.8 Undesirable effects

The most common adverse effect of the sedating antihistamines is CNS depression. Effects vary from slight drowsiness to deep sleep, and include lassitude, dizziness, and incoordination. Paradoxical stimulation may occasionally occur, especially at high doses and in children and the elderly. If sedative effects occur, they may diminish after a few days of treatment. Other common adverse effects include headache, psychomotor impairment and antimuscarinic effects.

Undesirable effects are listed by MedDRA System Organ Classes.

Assessment of undesirable effects is based on the following frequency groupings:

Very common: ?1/10

Common: ?1/100 to <1/10

Uncommon: ?1/1,000 to <1/100

Rare: ?1/10,000 to <1/1,000

Very rare: <1/10,000

Not known: cannot be estimated from the available data

System Organ Class Undesirable Effect Frequency
Blood and lymphatic system disorders blood disorders, including agranulocytosis, leucopenia, haemolyticanaemia, and thrombocytopenia Not known
Immune system disorders hypersensitivity reactions, anaphylaxis, angioedema Not known
Metabolic and nutritional disorders porphyria, anorexia Not known
Psychiatric disorders agitation, confusion, disorientation, hallucinations, sleep disturbances, depression, increased anxiety, nightmares Not known
Nervous system disorders dyskinesia4, insomnia, sedation, drowsiness, dizziness, weakness, headache, tremor1?convulsions2, psychomotor impairment, paraesthesias, extrapyramidal effects, seizure, coma, somnolence, disturbance in attention, involuntary motor activity3, ataxia, slurred speech, bitter taste in mouth, faintness Not known
Eye disorders accommodation disorder, blurred vision Not known
Ear and labyrinth disorders tinnitus, labrynthitis, vertigo Not known
Cardiac disorders ventricular arrhythmias (e.g. Torsade de Pointes), QT interval prolongation (see section 4.4), tachycardia, palpitation Not known
Vascular disorders hypotension, flushing Not known
Respiratory, thoracic and mediastinal disorders bronchospasm, thickened respiratory tract secretions, wheezing, nasal stuffiness, dryness of throat Not known
Gastrointestinal disorders constipation, dryness of the mouth, nausea, vomiting, increased gastric reflux, diarrhoea, epigastric pain, increased GI peristalsis Not known
Hepatobiliary disorders liver dysfunction Not known
Skin and subcutaneous tissue disorders dermatitis, fixed drug eruption, pruritis, erythema, papular rash, sweating increased, urticaria, hair loss, eczema, acute generalisedexanthematouspustulosis (AGEP), toxic epidermal necrolysis

Stevens-Johnson syndrome, erythema multiforme

Not known

 

 

 

Very rare

Muscoskeletal and connective tissue disorders myalgia Not known
Renal and urinary disorders urinary retention, dysuria Not known
Reproductive system and breast disorders priapism, impotence, early menses Not known
General disorders and administration site conditions fatigue, malaise, lassitude, pyrexia, dryness of respiratory mucosae, asthenia, tightness of chest, irritability, chills Not known
Investigations liver function tests abnormal Not known

Footnotes

1,2, 3?reported usually with doses considerably higher than those recommended. Continuous therapy with over 1g/day has been employed in some patients without these effects having been encountered

4?dyskinesia may follow termination of prolonged antihistamine therapy.

Children and the elderly are more susceptible to side-effects.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Overdosage with sedating antihistamines is associated with antimuscarinic, extrapyramidal, and CNS effects. If CNS stimulation predominates over CNS depression, ataxia, excitement, seizures, tremors, psychoses, hallucinations, convulsions and hyperpyrexia can occur. Coma and cardiorespiratory collapse may follow. CNS stimulation is more likely in children and elderly. In adults, CNS depression is more common with drowsiness, postictal depression, coma, and convulsions, progressing to respiratory failure and cardiovascular collapse. In children and adults, cerebral oedema and upper nephron nephrosis, a deepening coma, tachycardia, QRS widening, heart block, cardiorespiratory collapse/arrest, cardiogenic shock, and death may occur.

Common features include excessive sedation, nausea, vomiting, flushing, dilated pupils, dry mouth and tongue, hot dry skin, fever, sinus tachycardia, hypertension, ataxia, nystagmus, delirium, agitation, psychosis and visual hallucinations. Uncommon systemic features include myoclonic jerking, muscle rigidity, coma, convulsions, cardiac conduction abnormalities, QT prolongation and arrhythmias, cardiovascular collapse, paralytic ileus, urinary retention, hyperkalaemia, metabolic acidosis and rhabdomyolysis.

Peak concentrations occur approximately two hours post ingestion, and elimination half-life has been reported approximately 14 hours and 20 hours post ingestion (see section 5.2 ‘Pharmacokinetic properties’).

There is no specific antidote. It is doubtful whether haemodialysis or peritoneal dialysis has any value in the treatment of overdosage with Hydroxyzine Hydrochloride . However, if other agents such as barbiturates have been ingested concomitantly, dialysis may be indicated.

Consider activated charcoal only if the patient presents within 1 hour of ingestion of a potentially toxic amount. Gastric lavage is rarely required; for substances that cannot be removed effectively by other means, it should be considered only if a life-threatening amount has been ingested within the previous hour. It should be carried out only if the airway can be protected adequately. Induction of emesis is not recommended.

General supportive care, including frequent monitoring of the vital signs and close observation of the patient is indicated. Clear airways should be maintained, and there should be adequate ventilation. Assisted ventilation is indicated if hypercapnia is present. Observation for 6 hours after ingestion, without any other specific treatment, will be sufficient for the majority of patients. Monitor BP, pulse and body temperature. In symptomatic patients measure U&Es and creatine kinase. Perform a 12-lead ECG and monitor cardiac rhythm. Patients who have been unconscious may be hypothermic.

Hypotension, though unlikely, may be controlled with intravenous fluids. In adults, if severe hypotension persists, determine the cause and consider treatment with the following; if hypotension is mainly due to decreased systemic vascular resistance, drugs such as noradrenaline or high dose dopamine may be beneficial, if hypotension is due to reduced cardiac output dobutamine, or in severe cases adrenaline may be beneficial. However it should be noted that hydroxyzine has been shown to inhibit and reverse the vasopressor effect of adrenaline.

Analeptic agents should not be used since they may cause seizures.

As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Anxiolytics

Hydroxyzine Hydrochloride? is unrelated chemically to benzodiazepines, phenothiazines, reserpine and meprobamate.

Mechanism of action

Hydroxyzine is a first generation antihistamine, a piperazine derivative, with antimuscarinic and sedative properties.

Antihistamines act as competitive antagonists of histamine at H1?histamine receptors, thus inhibiting H1?receptor-mediated reactions, such as vasodilation, flare and itch reactions and sneezing.

First-generation H1?antagonists easily cross the blood-brain barrier, consequently producing well-documented sedative and anticholinergic effects.

First-generation antihistamines also have affinity for 5-HT receptors, alpha-adrenoreceptors, and muscarinic receptors. They also reduce cyclic GMP concentrations, increase atrioventricular nodal conduction, and inhibit activation of airway vagal afferent nerves.

Pharmacodynamic effects

Hydroxyzine has CNS depressant, anticholinergic, antispasmodic, and local anaesthetic activity, in addition to antihistaminic effects. The drug also has sedative, antiemetic and primary skeletal muscle relaxant activity.

An onset of sedative action of hydroxyzine is usually noted within 15 to 30 minutes after oral administration. Sedative effects persist for 4-6 hours following administration of a single dose.

Hydroxyzine suppresses the inflammatory response (wheal and flare reaction) and pruritus for up to 4 days after intradermal skin tests with allergens and histamine.

The therapeutic range for plasma hydroxyzine concentrations and the relationship of plasma concentration to clinical response or toxicity have not been established.

Hydroxyzine does not appear to increase gastric secretions or acidity, and usually has mild antisecretory effects.

It induces a calming effect in anxious tense adults. It is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system.

Clinical efficacy and safety

Hydroxyzine Hydrochloride? has been shown clinically to be a rapid-acting anxiolytic with a wide margin of safety.

Antihistamine effects have been demonstrated experimentally and confirmed clinically; it is highly effective in alleviating pruritus.

Paediatric population

The pharmacokinetics and antipruritic effects of hydroxyzine were studied in 12 children (mean age 6.1 +/- 4.6 years) with severe atopic dermatitis, each given a single 0.7 mg/kg oral dose. Pruritis was significantly suppressed from 1 to 24 hours after the administration of the dose, with greater than 85% suppression from 2 to 12 hours. The potent antipruritic effect persists even when serum concentrations of the drug are low (only 10% of the maximum levels achieved). In children, the biologic effects of hydroxyzine appear to be much more prolonged than would be predicted from the half life values.

5.2 Pharmacokinetic properties

Absorption

Hydroxyzine is rapidly absorbed from the gastrointestinal tract.

After a single oral dose of hydroxyzine, 0.7 mg/kg (mean dose 39.0 +/- 5.4 mg) a mean maximum serum hydroxyzine concentration of 72.5 +/- 11.1 ng/ml has been shown to occur at a mean time of 2.1 +/- 0.4 hours.

Distribution

Distribution of hydroxyzine into human body tissues and fluids has not been fully characterised. Following administration of hydroxyzine to animals, the drug is widely distributed into most body tissues and fluids with highest concentrations in the liver, lungs, spleen, kidneys, and adipose tissue. The drug is also distributed into bile in animals.

Hydroxyzine crosses the placental barrier which may lead to higher foetal than maternal concentrations.

Serum hydroxyzine concentrations do not necessarily reflect hydroxyzine tissue binding or distribution to skin receptor sites. Suppression of wheals, flares, and associated pruritis has been shown to persist even when serum hydroxyzine concentrations are low.

First-generation H1?antagonists easily cross the blood-brain barrier.

In a study group of healthy adults, the mean apparent volume of distribution has been found to be 16.0 +/- 3.0 L/kg.

Biotransformation

Hydroxyzine is metabolised in the liver. Metabolites include cetirizine, which has antihistaminic activity. Cetirizine is formed from hydroxyzine via an oxidative biotransformation step.

Elimination

An elimination half life of 20.0 +/- 4.1 hours and of 14.0 hours has been reported for hydroxyzine.

Total body clearance in adults is generally in the range of 5 to 12 ml/min/kg.

Hydroxyzine is eliminated by hepatic metabolism in humans. Cetirizine is mainly renally excreted.

Special populations

Elderly patients

The pharmacokinetics of hydroxyzine were studied in nine healthy elderly (mean age 69.5 +/- 3.7 years) subjects who ingested a single dose of hydroxyzine, 0.7 mg/kg (mean dose 49.0 +/- 6.7 mg). The mean serum elimination half life value of hydroxyzine in this elderly group was 29.3 +/-10.1 hours (range 20.2 to 53.3 hours), which was significantly longer than that reported in younger subjects. The mean apparent volume of distribution of hydroxyzine in this elderly group was 22.5 +/- 6.3 L/kg (range 13.4 to 30.7L/kg), which was significantly larger than that reported to be found in young adults. Hydroxyzine has a long mean serum elimination half life value, a large volume of distribution and a prolonged pharmacodynamics effect (suppressive effect on wheal and flare response to histamine) in the elderly.

In the elderly a number of age-related biological and physiological changes may have an effect on the pharmacology of hydroxyzine and its metabolite, cetirizine. These changes may impact upon the pharmacologic functions of absorption, distribution, metabolism, excretion, and receptor sensitivity.

Dosage reduction may be appropriate in elderly patients (see section 4.2 ‘Posology and Method of Administration’)

Paediatric patients

The pharmacokinetics and antipruritic effects of hydroxyzine hydrochloride was studied in 12 children aged 1 to 14 years (mean age 6.1 +/- 4.6 years) with severe atopic dermatitis. The children were given a single orally administered dose of 0.7 mg/kg hydroxyzine. The mean peak serum concentration of 47.4 +/- 17.3 ng/ml occurred at a mean time of 2.0 +/- 0.9 hours. Terminal elimination half life was shorter in children than in adults, at a mean of 7.1+/- 2.3 hours. This resulted from a larger clearance rate in children of 32.08 +/- 11.05 ml/min/kg. The elimination half-life values increased with increasing age. Half life values were approximately 4 hours in the 1 year old patients and 11 hours in the 14 year old patient.

Dosage should be adjusted in the paediatric population (see section 4.2 ‘Posology and Method of Administration’)

Hepatic impairment

The pharmacokinetics and pharmacodynamics of hydroxyzine were studied in eight patients (mean age 53.4 +/- SD11.2 years) with primary biliary cirrhosis, given a single dose of 0.7 mg/kg (mean dose 43.9 +/- 6.6mg) hydroxyzine. All patients had abnormal liver biochemistry tests, all had biopsies compatible with primary biliary cirrhosis, and seven of eight had positive tests for antimitochondrial antibodies.

Hydroxyzine elimination was found to be impaired in patients with primary biliary cirrhosis. Mean peak hydroxyzine levels occurring at 2.3 +/- 0.7 hours were found to be 116.5 +/- 60.6 ng/ml, which was significantly higher than in other patient groups studied previously. Mean serum elimination half-life of hydroxyzine was 36.6 +/- 13.1 hours, which was significantly longer than in patients with normal hepatic function studied previously.

Dosage should be adjusted in patients with hepatic impairment (see section 4.2 ‘Posology and Method of Administration’)

Renal impairment

The pharmacokinetics of hydroxyzine and of its active metabolite cetirizine were studied in patients with reduced kidney function. Eight healthy volunteers and eight patients with renal insufficiency received a single peroral dose of 50 mg hydroxyzine.

With regards to hydroxyzine, results showed moderate elevation of the average terminal half-life in the patients group (t1/2?14 vs. 23 h). The areas under the concentration-time curves (AUC) were 996 ng?h?ml-1?in the healthy volunteers group and 1621 ng?h?ml-1?in the patients group. For cetirizine, AUC measured 6036 ng?h?ml-1?in the healthy volunteers group and 31635 ng?h?ml-1?in the patients group. The study concluded that the reduced renal clearance of cetirizine may be of clinical importance in patients with renal failure.

Dosage should be adjusted in patients with renal impairment (see section 4.2 ‘Posology and Method of Administration’)

5.3 Preclinical safety data

None stated.

  1. Pharmaceutical particulars

6.1 List of excipients

Lactose anhydrous, Calcium Phosphate Dibasic Anhydrous, Pregelatinised Starch, Magnesium Stearate, Sodium Lauryl Sulfate, Silicon Dioxide.

6.2 Incompatibilities

Hydroxyzine hydrochloride has been reported to be incompatible with aminophylline, benzylpenicillin salts, chloramphenicol sodium succinate, dimenhydrinate, doxorubicin hydrochloride (in a liposomal formulation), thioridazine, and some soluble barbiturates.

6.3 Shelf life

24 Months.

6.4 Special precautions for storage

Do not store above 25?C.

6.5 Nature and contents of container

Alu Blister Pack.

6.6 Special precautions for disposal and other handling

No special requirements.

7. 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

Hydroxyzine HCl Tablets USP 10mg/25mg/50mg Taj Pharma
(Hydroxyzine HCl)

Package leaflet: Information for the patient

Read all of this leaflet carefully before you start taking this medicine

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.

The information in this leaflet has been divided into the following sections:

  1. What Hydroxyzine is and what it is taken for
    2. What you need to know before you take Hydroxyzine
    3. How to take Hydroxyzine
    4. Possible side effects
    5. How to store Hydroxyzine
    6. Further information

 

  1. What Hydroxyzine is and what it is taken for

Hydroxyzine? belongs to a group of medicines called antihistamines (used to treat allergic reactions). It is used in adults and children to reduce itching caused by urticaria (nettle rash) and dermatitis (eczema).

Hydroxyzine? is also used to treat anxiety in adults.

  1. What you need to know before you take Hydroxyzine

Do not take Hydroxyzine

  • if you are allergic (hypersensitive) to Hydroxyzine, cetirizine, other piperazine derivatives, aminophylline or ethylenediamine, or any of the ingredients of Hydroxyzine (see Section 6 Further information)
  • if your ECG (electrocardiogram) shows a heart rhythm problem called ?QT interval prolongation?
  • if you have or had a cardiovascular disease or if your heart rate is very low
  • if you have low salt levels in your body (e.g. low level of potassium or of magnesium)
  • if you are taking certain medicines for heart rhythm problems or medicines that may affect the heart rhythm (see ?Other medicines and Hydroxyzine ?)
  • if anyone in your close family has died suddenly of heart problems
  • if you are an asthmatic who has suffered a bad reaction to an antihistamine in the past
  • if you have porphyria (a disease which causes stomach pain, constipation, changes in the colour of urine, skin rashes and disturbed behaviour)
  • if you are pregnant, trying to become pregnant or breast-feeding.

Hydroxyzine? contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. If you have hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactosemalabsorption you should not take this medicine.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take Hydroxyzine .

Warnings and precautions

Hydroxyzine? may be associated with an increased risk of heart rhythm disorder which may be life threatening. Therefore, tell your doctor if you have any heart problems or are taking any other medicines, including medicines obtained without prescription.

While taking Hydroxyzine ,?seek immediate medical attention?if you experience heart problems such as palpitations, trouble breathing, loss of consciousness. Treatment with hydroxyzine should be stopped.

Before you take Hydroxyzine? tell your doctor if you suffer with:

  • kidney disease or are on dialysis
  • liver disease. Hydroxyzine is not suitable for patients with severe liver disease or liver failure
  • glaucoma (increased pressure in the eye)
  • difficulty passing water e.g. due to an enlarged prostate
  • digestive system or stomach problems
  • myasthenia gravis (a muscle weakness disorder)
  • dementia
  • seizure disorders including epilepsy (fits)
  • breathing problems
  • bladder outflow obstruction
  • hyperthyroidism (often referred to as an ?overactive thyroid?)
  • high blood pressure (hypertension)

Your doctor may adjust your dose if you are elderly.

Hydroxyzine? may affect the results of some tests for allergy or asthma. Always tell your doctor or nurse that you have been given Hydroxyzine? recently.

If the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take Hydroxyzine .

Other medicines and Hydroxyzine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without prescription. Hydroxyzine? can affect or be affected by other medicinal products.

Do not take Hydroxyzine? if you are taking medicine to treat:

  • bacterial infections (e.g. the antibiotics erythromycin, moxifloxacin, levofloxacin)
  • fungal infections (e.g. pentamidine)
  • heart problems or high blood pressure (e.g. amiodarone, quinidine, disopyramide, sotalol)
  • psychoses (e.g. haloperidol)
  • depression (e.g. citalopram, escitalopram)
  • gastro-intestinal disorders (e.g. prucalopride)
  • allergy
  • malaria (e.g. mefloquine)
  • cancer (e.g. toremifene, vandetanib)
  • drug abuse or severe pain (methadone)

It is also important that you tell your doctor if you are taking any of the following medicines:

  • adrenaline or epinephrine
  • barbiturates (for sleeping disorders and epilepsy)
  • cimetidine (for ulcers and heartburn)
  • antiemetics (drugs effective against vomiting and nausea)
  • betahistine (used to treat a condition called M?ni?re?s disease)
  • anaesthetics
  • muscle relaxants
  • opioids (medicines for relieving severe pain)anticholinergic medicines, these include some medicines used for irritable bowel syndrome, asthma or incontinence
  • aminophylline (for breathing problems)
  • benzylpenicillin salts and chloramphenicol sodium succinate (antibiotics)
  • doxorubicin hydrochloride (a chemotherapy drug)
  • antidepressants, including monoamine oxidase inhibitors (MAOIs) (such as isocarboxazid or moclobemide), and tricyclics (such as amitriptyline) medicines to treat anxiety
  • medicines that help you sleep
  • benzodiazepines
  • anticholinesterase medicines (such as edrophonium and neostigmine)
  • antimuscarinic medicines (such as atropine)
  • antiepileptic medicines
  • other antihistamines

Taking with food and drink

You should not take alcohol with Hydroxyzine? because the sedative effects of the alcohol may be increased.

Pregnancy and breast-feeding

Do not take Hydroxyzine? if you are pregnant, trying to become pregnant or breast-feeding. If you become pregnant whilst taking Hydroxyzine? tell your doctor immediately.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Hydroxyzine? may make you drowsy and make you feel less alert than usual for the first few days after you start taking it. If you are affected do not drive or operate machinery until this effect has worn off.

Important information about some of the ingredients of Hydroxyzine

Hydroxyzine? 10mg and 25mg film-coated tablets contain lactose, if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Hydroxyzine? 10mg film-coated tablets contain Sunset yellow (E110), which may cause allergic reactions.

  1. How to take Hydroxyzine

Always take this medicine exactly as your doctor or pharmacist has told you to. You should check with your doctor or pharmacist if you are not sure.

Hydroxyzine? should be used at the lowest effective dose and the treatment period should be as short as possible.

The recommended dose is:

In adults and children over 40 kg in weight, the maximum daily dose is 100 mg per day in all indications.

For treating itching in adults

The starting dose is 25mg at night, your doctor may increase the dose up to 25mg three or four times daily.

Children and adolescents

For treating itching in children

In children up to 40 kg in weight, the maximum daily dose is 2 mg/kg/day.

Children aged 6 months to 6 years:

5mg to 15mg daily taken throughout the day, the doctor may change this depending on the child?s weight.

Children over 6 years:

15mg to 25mg daily which your doctor may increase up to 50mg – 100mg daily, taken throughout the day. The doctor may change this depending on the child?s weight.

For treating anxiety in adults

The dose is 50mg to 100mg daily, taken throughout the day.

For patients with liver disease

Your doctor will reduce your dose by about one third if you have liver disease.

Hydroxyzine? is not suitable for patients with severe liver disease or liver failure

For patients with kidney disease

Your doctor will reduce your dose by about half if you have kidney disease.

For elderly patients

In the elderly, the maximum daily dose is 50 mg per day.

If you take more Hydroxyzine? than you should

If you have used or taken too much Hydroxyzine ,?immediately?contact your doctor or the nearest accident and emergency department, in particular if a child has taken too much. In the event of overdose, symptomatic treatment could be implemented. An ECG monitoring could be undertaken, because of the possibility of a heart rhythm problem such as QT interval prolongation or Torsade de Pointes.

Symptoms of an overdose can vary and may include:

  • slowing of your thoughts, slurred speech and experiencing restless, involuntary or slow movements
  • dry mouth, problems with your vision, fast or pounding heart beat, difficulty passing water and constipation
  • slowing down of your central nervous system, which can slow your breathing and heart rate, cause you to feel drowsy or become unconscious. Or, you may experience stimulation of your central nervous system, with feelings of excitement, fits, shaking and hallucinations.

Hydroxyzine? can cause considerable sedation that requires treatment.

If any other medicines or substances have been taken at the same time as Hydroxyzine? tell the medical staff carrying out the treatment of the overdose.

If you forget to take Hydroxyzine

If you forget to take a dose, take it as soon as possible, unless it is almost time to take the next dose. Do not take a double dose. Then go on as before.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

  1. Possible side effects

Do not worry. Like all medicines, Hydroxyzine? can cause side effects, although not everyone gets them. Hydroxyzine? can cause the following side effects in some people:

If you get any of the following symptoms after taking Hydroxyzine , stop taking the medicine and seek immediate medical attention:

  • Symptoms of a severe allergic reaction such as;
  • Swelling of the face, tongue or throat
    • Difficulties in swallowing
    • Hives and difficulties in breathing
  • Severe reactions that can include blistering of the skin, eyes, mouth and genitals
  • Tremor (shakiness) or convulsions (fits)
  • if you experience any problems with the heart rhythm such as palpitations, trouble breathing or loss of consciousness.

Other possible side effects of Hydroxyzine? include:

  • drowsiness, sedation, coma, slurred speech, slowing of thought processes and movements, involuntary movements, dizziness, faintness, headache, inability to concentrate, sleep disturbances, bitter taste in mouth
  • confusion, hallucinations, disorientation, unusual mood changes
  • bloodshot eyes, blurred vision and difficulty in focussing
  • faster or pounding heart beat
  • low blood pressure, flushing
  • dryness of the nose, mouth or throat, wheezing
  • liver problems (symptoms include jaundice)
  • difficulty or pain when passing water, blood in urine
  • tiredness, general feeling of being unwell, fever, chills, muscle pain, chest tightness, achy joints
  • porphyria (a rare illness which affects the metabolism), anorexia
  • blood disorders
  • skin rashes, swelling, itching, hives, eczema, increased sweating, hair loss, tingling, prickling, numbing of skin, pus-filled skin sores
  • prolonged penile erection, impotence, early menstruation
  • hearing, balance or coordination problems
  • digestive system or stomach problems, feeling or being sick, diarrhoea, constipation

Reporting of side effects

If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

  1. How to store Hydroxyzine

Keep this medicine out of the sight and reach of children.

Do not take Hydroxyzine? after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25?C.

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

  1. Further information

What is in Hydroxyzine ?

The active ingredient is Hydroxyzine.

a) Each Film Coated Tablet Contains:
Hydroxyzine Hydrochloride USP? ? 10mg
Excipients? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? q.s

b) Each Film Coated Tablet Contains:
Hydroxyzine Hydrochloride USP? ? 25mg
Excipients? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? q.s

c) Each Film Coated Tablet Contains:
Hydroxyzine Hydrochloride USP? ?50mg
Excipients? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? q.s

The other ingredients are:

Calcium phosphate, lactose, magnesium stearate, maize starch, silicon dioxide and sodium lauryl sulfate.

What Hydroxyzine? looks like and contents of the pack

Hydroxyzine round circular film-coated tablets.

Available in Aluminium/Blister Packs.

Pack Size: 7, 14, 28, 30, 50, 100 and 500 film-coated tablets.

Not All Packs May Be Marketed.

7. 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

Leave a Reply

What people say about our doctor?

Loading…

More from Portfolio

Loading…
  • Imatinib Capsules 100mg Taj Pharma

    NAME OF THE MEDICINAL PRODUCT Imatinib Capsules 100mg Taj Pharma QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard gelatin capsule contains: Imatinib Mesylate Equivalent to Imatinib? ? ? ? ? 100mg Excipients? ? ? ? ? ? ? ? ? ? ? ? ? ? ? q.s Colours: Approved colours used in the capsule shell For the […]

  • Lisinopril Tablets USP 40mg Taj Pharma

    Name of the medicinal product Lisinopril Tablets USP 2.5mg Taj Pharma Lisinopril Tablets USP 5mg Taj Pharma Lisinopril Tablets USP 10mg Taj Pharma Lisinopril Tablets USP 20mg Taj Pharma Lisinopril Tablets USP 30mg Taj Pharma Lisinopril Tablets USP 40mg Taj Pharma Qualitative and quantitative composition a) Each Tablet Contains: Lisinopril USP (as dihydrate)? ? ? […]

  • Indapamide Tablets USP 1.25mg Taj Pharma

    Name of the medicinal product Indapamide Tablets USP 1.5mg Taj Pharma Indapamide Tablets USP 1.25mg Taj Pharma Indapamide Tablets USP 2.5mg Taj Pharma Qualitative and quantitative composition a) Each tablet contains: Indapamide USP? ? ?1.5mg Excipients? ? ? ? ? ? ? ? ? q.s b) Each tablet contains: Indapamide USP? ? 1.25mg Excipients? ? […]

  • Cyclophosphamide for Injection USP 500mg Taj Pharma

    NAME OF THE MEDICINAL PRODUCT Cyclophosphamide for Injection USP 200mg Taj Pharma Cyclophosphamide for Injection USP 500mg Taj Pharma Cyclophosphamide for Injection USP 1000mg Taj Pharma QUALITATIVE AND QUANTITATIVE COMPOSITION a) Cyclophosphamide for Injection USP 200mg Taj Pharma Each vial contains cyclophosphamide monohydrate USP Equivalent to Cyclophosphamide (anhydrous) 200mg b) Cyclophosphamide for Injection USP 500mg […]