Tussoretardin

Carbetapentane Citrate:

• Poly hist cb
• Clinical pharmacology:
• Indications and usage:
• Contraindications:
• Warnings:
• Precautions:
• Carcinogenesis, mutagenesis, and impairment of fertility:
• Pregnancy:
• Nursing mothers:
• Adverse reactions:
• Overdosage:
• Dosage and administration:
• How supplied:
• Product packaging:
• Tussoretardin (Carbetapentane Citrate) reviews

POLY HIST CB

Antitussive/Expectorant

Rx Only

Description: POLY HIST CB is an alcohol-free, sugar-free, purple liquid for oral administration

having a grape odor and flavor.

Each Teaspoon (5 mL) Contains:

Tussoretardin (Carbetapentane Citrate) CITRATE... 20 mg

GUAIFENESIN...75 mg

POLY HIST CB Liquid also contains: FD and C Blue #1, FD and C Red #40, Grape Flavor, Maltitol,

Propylene Glycol, Sodium Saccharin, Sorbitol, Purified Water.

Clinical

Pharmacology:

Tussoretardin (Carbetapentane Citrate) citrate is a centrally acting non-narcotic antitussive.

Guaifenesin is an expectorant. Its action increases the output of respiratory tract fluid by reducing

adhesiveness and surface tension. Sinus and bronchial drainage is improved and dry, nonproductive

coughs become more productive and less frequent.

Indications And Usage:

for temporary relief of non-productive cough accompanying respiratory tract congestion associated with

the common cold, influenza, sinusitis, and bronchitis.

Contraindications:

POLY HIST CB is contraindicated in infants and newborns, and in patients with a known

hypersensitivity to any of the components. It is also contraindicated in patients on MAO inhibitor therapy.

Warnings:

A persistent cough may be a sign of a serious condition. If cough persists for more than one week

or tends to recur, or is accompanied by fever, rash, or persistent headache, patient reevaluation

should be considered.

Precautions:

DRUG INTERACTIONS: Guaifenesin may produce an increase in urinary 5-hydroxy-indoleacetic 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.

Carcinogenesis, Mutagenesis, And Impairment of Fertility:

No adequate and well controlled studies have been conducted to determine whether the components

of POLY HIST CB have a potential for carcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy:

Pregnancy Category C: Animal reproduction studies have not yet been conducted with this product.

It is not known whether it can cause fetal harm when administered to a pregnant woman or can affect

reproduction capacity. This product should not be administered to pregnant women.

Nursing Mothers:

Due to the possible passage of the ingredients into breast milk, this product should not be given to nursing mothers.

Adverse Reactions:

Guaifenesin is well tolerated and has a wide margin of safety. Side effects are generally

mild and infrequent. Nausea and vomiting are the most common side effects. Dizziness,

headache, and rash (including urticaria) have been reported rarely.

Overdosage:

SIGNS AND SYMPTOMS: Incidence of acute toxicity with guaifenesin is low and over dosage

is unlikely to produce serious toxic effects. In laboratory animals no toxicity resulted when

guaifenesin was administered by stomach tube in doses up to 5 grams/kg.

TREATMENT: Treatment of the signs and symptoms of overdosage is symptomatic and

supportive. The patient should be induced to vomit, even if emesis has occurred spontaneously.

Pharmacologic vomiting by the administration of ipecac syrup is a preferred method, however,

vomiting should not be induced in patients with impaired consciousness. Precautions against

aspiration must be taken, especially in infants and children. Following emesis, any drug

remaining in the stomach may be absorbed by activated charcoal administered as a slurry with water.

Dosage and Administration:

POLY HIST CB is administered orally as follows:

Adults: 1-2 teaspoonfuls every 4-6 hours or as directed by a physician.

Children 6-12 years of age: 1 teaspoonful every 4-6 hours or as directed by a physician.

Children 2-6 years of age: 1/2 teaspoonful every 4-6 hours or as directed by a physician.

Children under 2 years of age: As directed by a physician.

How Supplied:

16 fluid ounce bottles NDC # 50991-781-16 and 15 mL bottles NDC # 50991-781-15

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

IN CASE OF ACCIDENTAL OVERDOSAGE, CONTACT A POISON CONTROL

CENTER AND SEEK PROFESSIONAL ASSISTANCE IMMEDIATELY.

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Store at controlled room temperature, 59^o-86^oF (15^o-30^oC).

DISPENSE IN TIGHT, LIGHT RESISTANT CONTAINERS WITH CHILD RESISTANT CLOSURES

AS DEFINED IN THE USP/NF.

Manufactured for:

Poly Pharmaceuticals

Mobile, AL 36619

Rx Only

Rev. 11/09

PRODUCT PACKAGING:

The packaging below represents the labeling currently used:

NDC 50991-781-16

Poly Hist CB

Grape Flavor

Sugar Freee Alcohol Free

Antitussive/Expectorant

Each 5 mL (1 teaspoonful) contains:

Tussoretardin (Carbetapentane Citrate) Citrate... 20 mg

Guaifenesin... 75 mg

Distributed by:

Poly Pharmaceuticals

Mobile, AL 36619

Rx Only

16 fl oz (473 mL)

Side Panel:

USUAL

Dosage: Adults 12 years and older: 1-2 teaspoonfuls every 4-6 hours.

Children 6-12 years of age: 1 teaspoonful every 4-6 hours. Children 2-6 years of age:

1/2 teaspoonful every 4-6 hours. Children under 2 years of age: As directed by a physician.

See package insert for complete prescribing information.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

IN CASE OF ACCIDENTAL OVERDOSAGE, CONTACT A POISON CONTROL

CENTER AND SEEK PROFESSIONAL ASSISTANCE IMMEDIATELY.

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

This bottle is not to be dispensed to consumer.

STORAGE: Store at controlled room temperature, 59^o-86^oF (15^o-30^oC).

Mfg. for: Poly Pharmaceuticals, Mobile, AL 36619

Mfg. by: Great Southern Laboratories. Houston, TX 77099

Rev. 11/09

Poly Hist CB Packaging Poly Hist CB Packaging

Diphenhydramine Hydrochloride:

• Pharmacological action
• Pharmacokinetics
• Why is Tussoretardin Xepa-Soul Pattinson prescribed?
• Dosage and administration
• Tussoretardin (Diphenhydramine Hydrochloride) Xepa-Soul Pattinson side effects, adverse reactions
• Tussoretardin Xepa-Soul Pattinson contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• Precautionary measures
• Tussoretardin (Diphenhydramine Hydrochloride) Xepa-Soul Pattinson drug interactions
• Tussoretardin Xepa-Soul Pattinson in case of emergency / overdose
• Tussoretardin (Diphenhydramine Hydrochloride) reviews

Pharmacological action

Tussoretardin Xepa-Soul Pattinson is a blocker of histamine H1-receptors. It has antiallergic activity, has a local anesthetic, antispasmodic and mild ganglion blocking action.

When Tussoretardin (Diphenhydramine Hydrochloride) Xepa-Soul Pattinson administered orally Tussoretardin (Diphenhydramine Hydrochloride) has a sedative and hypnotic effects, has a moderate antiemetic effect and has a central holinoliticheskoy activity.

When applied externally it has antiallergic effect.

Pharmacokinetics

Tussoretardin (Diphenhydramine Hydrochloride) Xepa-Soul Pattinson is rapidly absorbed from the gastrointestinal tract. Bioavailability is 50%. C_max is achieved after 20-40 min (in the greatest concentration is determined in the lungs, spleen, kidneys, liver, brain and muscles). Binding to plasma proteins - 98-99%. Penetrates through the BBB. Metabolised mainly in the liver, partly - in the lungs and kidneys. T1/2 is 4-10 hours. Within one day completely removed kidneys as metabolites conjugated to glucuronic acid. Significant quantities are derived from milk and can cause sedation in infants (may be a paradoxical reaction characterized by hyperexcitability).

Why is Tussoretardin Xepa-Soul Pattinson prescribed?

Allergic reactions (urticaria, hay fever, angioedema), allergic conjunctivitis, vasomotor rhinitis, Henoch-Schonlein purpura, serum sickness, itchy dermatitis, sleep disorders (monotherapy or in combination with drugs), chorea, sea and air sickness, vomiting in pregnancy, Meniere's syndrome, premedication.

Dosage and administration

Oral, IV, IM, rectal, topical, intranasal, in the conjunctival sac. Oral dose of Tussoretardin Xepa-Soul Pattinson for adults is 30-50 mg 1-3 times / day. The treatment course is 10-15 days. As soporific - 50 mg at bedtime. IM in doses of 50-250 mg; IV in drip - 20-50 mg. When oral administered single dose for children under 1 year - 2-5 mg; from 2 to 5 years - 5-15 mg; of 6 to 12 years - 15-30 mg. Externally applied 1-2 times / day.

Tussoretardin (Diphenhydramine Hydrochloride) Xepa-Soul Pattinson side effects, adverse reactions

Possible: a short-term numbness in the oral mucosa, drowsiness, weakness, decrease in psychomotor speed of reaction in children may be a paradoxical development of insomnia, irritability, and euphoria.

Rarely: dizziness, headache, dry mouth, nausea, photosensitivity, paresis of accommodation, poor coordination of movements, tremor.

Tussoretardin Xepa-Soul Pattinson contraindications

Closure glaucoma, prostatic hypertrophy, stenosing peptic ulcer, stenosis of the bladder neck, bronchial asthma, epilepsy, hypersensitivity to Tussoretardin (Diphenhydramine Hydrochloride).

Using during pregnancy and breastfeeding

During pregnancy and lactation, Tussoretardin (Diphenhydramine Hydrochloride) used with caution, according to strict indications, when the expected therapeutic effect for the mother outweighs the potential risk to the fetus or infant.

Special instructions

With careful use Tussoretardin (Diphenhydramine Hydrochloride) during pregnancy and lactation.

During the period of treatment with Tussoretardin (Diphenhydramine Hydrochloride) Xepa-Soul Pattinson should not be exposed to solar radiation should be avoided alcohol.

Used with caution in patients involved in potentially dangerous activities requiring attention and rapid psychomotor reactions.

Precautionary measures

Tussoretardin Xepa-Soul Pattinson is not recommended for SC injection. Since Tussoretardin (Diphenhydramine Hydrochloride) has atropinopodobnym action should be cautious in its use: patients with recent respiratory infection in history (including asthma), increased intraocular pressure in hyperthyroidism, cardiovascular system, hypotension. Antihistamines drugs can reduce mental alertness as well as in adults and children and also cause agitation and hallucinations, convulsions and death in infants and children, especially in overdose. Precautions apply at age 60 and older because more likely to develop dizziness, sedation and hypotension. During treatment with Tussoretardin (Diphenhydramine Hydrochloride) should avoid sun exposure. Should not be used during the drivers of vehicles and people, trade is connected with increased concentration. In the period of treatment should avoid drinking alcoholic beverages.

Tussoretardin (Diphenhydramine Hydrochloride) Xepa-Soul Pattinson drug interactions

When Tussoretardin (Diphenhydramine Hydrochloride) Xepa-Soul Pattinson applied simultaneously increases the effects of ethanol and drugs that depress the central nervous system.

With simultaneous use of Tussoretardin (Diphenhydramine Hydrochloride) Xepa-Soul Pattinson and MAO inhibitors increase the anticholinergic activity of Tussoretardin (Diphenhydramine Hydrochloride).

The antagonistic interaction observed with a joint appointment with psychostimulants.

Reduces the effectiveness of apomorphine as an emetic in the treatment of poisoning. Intensifies anticholinergic effects of drugs with anticholinergic activity.

Tussoretardin Xepa-Soul Pattinson in case of emergency / overdose

Symptoms: dry mouth, difficulty breathing, persistent mydriasis, flushing, depression or excitement (more common in children), CNS confusion; children - the development of convulsions and death.

Treatment: induction of vomiting, gastric lavage, the prescription of activated charcoal, symptomatic and supportive therapy on a background of careful monitoring of respiration and blood pressure levels.