Medipax

Ammonium Chloride:

• Indications and usage
• Contraindications
• Warning
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Medipax (Ammonium Chloride) reviews

INDICATIONS AND USAGE

Medipax (Ammonium Chloride) Lactate Lotion, 12% is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris, and for the temporary relief of itching associated with these conditions.

CONTRAINDICATIONS

Medipax (Ammonium Chloride) Lactate Lotion, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

WARNING

Sun exposure (natural or artificial sunlight) to areas of the skin treated with Medipax (Ammonium Chloride) Lactate Lotion, 12% should be minimized or avoided (see PRECAUTIONS). The use of Medipax (Ammonium Chloride) Lactate Lotion, 12% should be discontinued if any hypersensitivity is observed.

PRECAUTIONS

General -

For external use only. Stinging or burning may occur when applied to skin with fissures, erosions, or that is otherwise abraded. Caution is advised when used on the face because of the potential for irritation. The potential for post-inflammatory hypo- or hyperpigmentation has not been studied.

Information for Patients

Patients using Medipax (Ammonium Chloride) Lactate Lotion, 12% should receive the following information and instructions:

• This medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. It is for external use only. Avoid contact with eyes, lips, or mucous membranes.
• Patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face. If sun exposure is unavoidable, clothing should be worn to protect the skin.
• This medication may cause transient stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs).
• If the skin condition worsens with treatment, the medication should be promptly discontinued.

Carcinogenesis, Mutagenesis, Impairment of Fertility -

The topical treatment of CD-1 mice with 12%, 21% or 30% Medipax lactate formulations for two-years did not produce a significant increase in dermal or systemic tumors in the absence of increased exposure to ultraviolet radiation. The maximum systemic exposure of the mice in this study was 0.7 times the maximum possible systemic exposure in humans. However, a long-term photocarcinogenicity study in hairless albino mice suggested that topically applied 12% Medipax (Ammonium Chloride) lactate formulations enhanced the rate of ultraviolet light-induced skin tumor formation.

The mutagenic potential of Medipax (Ammonium Chloride) lactate formulations was evaluated in the Ames assay and in the mouse in vivo micronucleus assay, both of which were negative.

In dermal Segment I and III studies with Medipax (Ammonium Chloride) lactate formulations there were no effects observed in fertility or pre- or postnatal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m²/day), approximately 0.4 times the human topical dose.

Pregnancy:

Teratogenic effects:

Pregnancy Category B -

Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively and have revealed no evidence of impaired fertility or harm to the fetus due to Medipax (Ammonium Chloride) lactate formulations. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Medipax (Ammonium Chloride) Lactate Lotion, 12% should be used during pregnancy only if clearly needed.

Nursing Mothers -

Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent this drug affects normal lactic acid levels in human milk. Because many drugs are excreted in human milk, caution should be exercised when Medipax (Ammonium Chloride) lactate is administered to a nursing woman.

Pediatric Use -

Safety and effectiveness of Medipax lactate have been demonstrated in infants and children. No unusual toxic effects were reported.

Geriatric Use -

Clinical studies of Medipax (Ammonium Chloride) lactate lotion, 12% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious.

ADVERSE REACTIONS

The most frequent adverse experiences in patients with xerosis are transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Other adverse reactions which occur less frequently are irritation, eczema, petechiae, dryness, and hyperpigmentation. Due to the more severe initial skin conditions associated with ichthyosis, there was a higher incidence of transient stinging, burning and erythema (each occurring in 1 in 10 patients).

OVERDOSAGE

The oral administration of Medipax (Ammonium Chloride) lactate to rats and mice showed this drug to be practically non-toxic (LD₅₀>15 mL/kg).

DOSAGE AND ADMINISTRATION

Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.

HOW SUPPLIED

Medipax Lactate Lotion, 12% is available as follows:

225 g bottle (NDC 45802-419-54)

400 g bottle (NDC 45802-419-26)

STORAGE

Store at 20-25°C (68-77°F).

Manufactured By Perrigo, Bronx, NY 10457

Distributed By Perrigo, Allegan, MI 49010

0K5A7 RC F6

Rev 01-17

Diphenhydramine Hydrochloride:

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

Pharmacological action

Medipax 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 Medipax (Diphenhydramine Hydrochloride) Xepa-Soul Pattinson administered orally Medipax (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

Medipax (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 Medipax 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 Medipax 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.

Medipax (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.

Medipax Xepa-Soul Pattinson contraindications

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

Using during pregnancy and breastfeeding

During pregnancy and lactation, Medipax (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 Medipax (Diphenhydramine Hydrochloride) during pregnancy and lactation.

During the period of treatment with Medipax (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

Medipax Xepa-Soul Pattinson is not recommended for SC injection. Since Medipax (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 Medipax (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.

Medipax (Diphenhydramine Hydrochloride) Xepa-Soul Pattinson drug interactions

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

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

Medipax 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.