Romilar Expectorant

Ammonium Chloride:

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

INDICATIONS AND USAGE

Romilar Expectorant (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

Romilar Expectorant (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 Romilar Expectorant (Ammonium Chloride) Lactate Lotion, 12% should be minimized or avoided (see PRECAUTIONS). The use of Romilar Expectorant (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 Romilar Expectorant (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% Romilar Expectorant 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% Romilar Expectorant (Ammonium Chloride) lactate formulations enhanced the rate of ultraviolet light-induced skin tumor formation.

The mutagenic potential of Romilar Expectorant (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 Romilar Expectorant (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 Romilar Expectorant (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, Romilar Expectorant (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 Romilar Expectorant (Ammonium Chloride) lactate is administered to a nursing woman.

Pediatric Use -

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

Geriatric Use -

Clinical studies of Romilar Expectorant (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 Romilar Expectorant (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

Romilar Expectorant 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

Dextromethorphan Hydrobromide:

• Pharmacological action
• Pharmacokinetics
• Why is Romilar Expectorant prescribed?
• Dosage and administration
• Romilar Expectorant (Dextromethorphan Hydrobromide) side effects, adverse reactions
• Romilar Expectorant contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• Romilar Expectorant drug interactions
• Romilar Expectorant in case of emergency / overdose
• Romilar Expectorant (Dextromethorphan Hydrobromide) reviews

Pharmacological action

Romilar Expectorant is an antitussive medication. Inhibiting the excitability of the cough center this medicine suppresses the cough of any origin. Romilar Expectorant (Dextromethorphan Hydrobromide) has not addiction effects and it has no analgesic and hypnotic action. Romilar Expectorant (Dextromethorphan Hydrobromide) starts to act after 10-30 minutes after oral administration, the duration of therapeutic action: 5-6 hours for adults and 6-9 hours for children. Romilar Expectorant (Dextromethorphan Hydrobromide) is an optical isomer of levomethorphan which is similar to morphine. Due to optical isomerism this drug has no opioid effects. Romilar Expectorant (Dextromethorphan Hydrobromide) used mainly for replacement of codeine as a cough suppressant. In addition to the cough suppressant this medication is used in medicine for diagnostic purposes and may be useful in various cases - from seizures to heroin addiction treatment, some chronic neurodegenerative diseases. These include amyotrophic lateral sclerosis (ALS) (Charcot's disease), disease of "mad cow and other prion diseases. Romilar Expectorant (Dextromethorphan Hydrobromide) has also been used for the treatment of mental retardation, Parkinson's disease, in the treatment of lung and other cancers and to prevent tissue rejection in transplantation because of the (poorly known) effects of sigma ligands on tumor cells and immune system.

Pharmacokinetics

After oral administration Romilar Expectorant (Dextromethorphan Hydrobromide) is completely absorbed from the gastrointestinal tract. C_max of Romilar Expectorant (Dextromethorphan Hydrobromide) in plasma is reached after 2 h. This medication biotransformes in the liver. Up to 45% of this drug is excreted by kidneys and there was considerable individual variation in rates of excretion of individual metabolites.

Why is Romilar Expectorant prescribed?

Dry cough of different etiology.

Dosage and administration

For adults and children over 12 years Romilar Expectorant prescribed on 15 mg 4 times / day, children aged 6 years - 7.5 mg 4 times / day.

Romilar Expectorant (Dextromethorphan Hydrobromide) side effects, adverse reactions

Drowsiness, nausea, dizziness.

Romilar Expectorant contraindications

Bronchial asthma, bronchitis, simultaneous reception of mucolytic.

Using during pregnancy and breastfeeding

During pregnancy and lactation (breastfeeding) Romilar Expectorant (Dextromethorphan Hydrobromide) prescribed with caution, only in cases where the expected therapeutic effect for the mother outweighs the potential risk to the fetus or child.

Special instructions

With carefully administered Romilar Expectorant (Dextromethorphan Hydrobromide) with impaired liver function.

Romilar Expectorant drug interactions

MAO inhibitors (including furazolidone, procarbazine, selegiline) when administered simultaneous with Romilar Expectorant (Dextromethorphan Hydrobromide) may cause adrenergic crisis, collapse, coma, dizziness, agitation, increased blood pressure, hyperpyrexia, intracranial hemorrhage, lethargy, nausea, cramps, tremor. In combination with tricyclic antidepressants (amitriptyline, etc.) Romilar Expectorant (Dextromethorphan Hydrobromide) may appeal serotonin syndrome and possible subsequent death. Amiodarone, fluoxetine, quinidine, inhibiting system cytochrome P450, may increase the drug concentration in the blood. Tobacco smoke can lead to increased secretion of glands in the background of inhibition of cough reflex. Some inhibitors of CYP450 (such as quinidine) increase and extended effects of this medicine.

Romilar Expectorant in case of emergency / overdose

Symptoms: excitement, dizziness, respiratory depression, impaired consciousness, decreased blood pressure, tachycardia, muscle hypertonicity, ataxia.

Treatment: mechanical ventilation, symptomatic agents.