Mucum is used to treat lungs and bronchial tubes diseases accompanied by secretion of viscous mucus. Mucum makes the mucus less viscous and thus facilitates its expectoration.

Children dosing

As a mucolytic, oral ambroxol has been given to children in doses of 1.5 to 2 milligrams/kilogram/day in 2 divided doses.

Recommended oral doses are as follows:

-   Children up to 2 years - 15 milligrams (mg) daily; in divided doses (2.5 mL of the syrup (one half of the teaspoonful) 2 times per day).

-   Children ages 2 to 5 years - 15 to 30 mg daily; in divided doses (2.5 mL of the syrup (one half of the teaspoonful) 3 times per day)

-   Children 5 to 12 years - 30 to 45 mg daily and in divided doses (5 mL of the syrup (one teaspoonful) 2-3 times per day)

-   Children 12 years and older - 60 to 90 mg daily; in divided doses (10 mL (two teaspoonful) of the syrup 2-3 times per day).

Mode of administration

Mucum syrup should be taken orally, after a meal, using the enclosed measure cup.

-        Ambroxol should be cautiously used in patients has experienced anaphylactic reactions and severe cutaneous adverse reactions including erythema, multiform, Stevens- Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis.

-      In children less than 2 years of age, Mucum may be used only under medical surveillance.

-        Ambroxol is not recommended for co-administration with: Cough-suppressing medicines (antitussive agents): No medicines that suppress the coughing reflex (so called antitussive medicines) should be used concomitantly with Mucum. The coughing reflex is important for expectoration of liquefied mucus and its removal from the lungs.

-        This medicine can be used simultaneously with antibiotics such as amoxicillin, cefuroxime, erythromycin and doxycycline, antibiotics penetration into lung tissues and their efficacy increase.

Pregnancy

During animal studies, there was no indication of direct or indirect harm with respect to pregnancy, embryofetal development, parturition, or postnatal development.

There are no adequate data on the use of ambroxol during human pregnancy and there is no evidence of fetal harm.

Breast-feeding

Available evidence and/or expert consensus is inconclusive or is inadequate for determining infant risk when used during breastfeeding. Weigh the potential benefits of drug treatment against potential risks before prescribing this drug during breastfeeding.

Administer to lactating women only if the potential benefit outweighs the potential risk to the infant.

Mucum either does not affect, or has only negligible impact on ability to drive vehicles and operate machines.

-   Dermatologic effects

Contact dermatitis, rash, pruritus, urticaria, exanthema, itching, pruritic erythema and vesicular eruptions about the nose, upper lips, and cheeks, and pharyngeal soreness and spasm have been reported with therapeutic use.

-   Gastrointestinal Effects

Dry mouth, diarrhea, excessive salivation, constipation, nausea and vomiting, xerostomia and sialorrhea have all been reported with therapeutic use.

-   Neurologic Effects

Fatigue was infrequently reported in patients receiving ambroxol therapy.

-   Renal Effects

Dysuria occurred infrequently with ambroxol therapy.

-   Respiratory Effects

Rhinorrhea reported in patients with ambroxol therapy.

-   Other

Fatigue was reported in 1 of 63 patients receiving ambroxol 60 to 120 milligrams/day for bronchitis

To report any side effect(s):

The National Pharmacovigilance and Drug Safety Centre (NPC)

Fax: +966-11-205-7662

Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.

Toll free phone: 8002490000

E-mail: npc.drug@sfda.gov.sa

Website: www.sfda.gov.sa/npc

Until now, there were no specific signs of overdose in humans. On the basis of reports of accidental overdose and / or errors in the treatment of the observed symptoms consistent with the known side effects of Ambroxol at recommended doses and may need symptomatic treatment.

Pharmacotherapeutic group: mucolytic agents.

ATC code: R05CB06.

Mucum is a mucolytic agent used in respiratory tract diseases.

Ambroxol is an active N-desmethyl metabolite of the mucolytic bromhexine. Although its mechanism of action has not been fully defined, it may increase the quantity and decrease the viscosity of tracheobronchial secretions. It may also act as an expectorant, increasing mucociliary transport via stimulation of ciliary motility.

Ambroxol may stimulate the synthesis and secretion of pulmonary surfactant; the drug has been referred to as a "surfactant activator”.

Absorption: Absorption of all non-delayed oral forms of ambroxol hydrochloride is rapid and complete, with dose linearity in the therapeutic range. Maximum plasma levels are reached within 1-2.5 hrs following oral administration of the immediate-release formulation and after a median of 6.5 hrs of the slow-release formulation. The absolute bioavailablility after a 30-mg tablet was found to be 79%. The slow-release capsule showed a relative availability of 95% (dose-normalized) in comparison to a daily dose of 60 mg (30 mg twice daily) administered as immediate-release tablet.
 

Distribution: In the therapeutic range, plasma protein-binding was found to be approximately 90%. Distribution of ambroxol hydrochloride from blood to tissue is rapid and pronounced, with the highest concentration of the active substance found in the lungs. The volume of distribution following oral administration was estimated to be 552 L.
 

Metabolism and Elimination: About 30% of an orally administered dose is eliminated via first-pass metabolism.

Studies in human liver microsomes have shown that CYP3A4 is responsible for the metabolism of ambroxol. Ambroxol hydrochloride is metabolized primarily in the liver by glucuronidation and some cleavage to dibromanthranilic acid (approximately 10% of dose) aside from some minor metabolites.

Ambroxol hydrochloride is eliminated with a terminal elimination half-life of approximately 10 hrs. Total clearance is in the range of 660 mL/min, with renal clearance accounting for approximately 8% of the total clearance.

Special Populations: In patients with hepatic dysfunction, elimination of ambroxol hydrochloride is reduced, resulting in approximately 1.3- to 2-fold higher plasma levels.
Due to the high therapeutic range of ambroxol hydrochloride, dose adjustments are not necessary.

Others: Age and gender were not found to affect the pharmacokinetics of ambroxol hydrochloride to a clinically relevant extent and thus, there is no necessity for adjustment of dosage regimens.

Food was not found to influence the bioavailability of ambroxol hydrochloride.

Ambroxol hydrochloride has a very low index of acute toxicity.

In studies with repeat administration of dose, upon oral doses of 150 mg / kg / day (mice, 4 weeks), 50 mg / kg / day (rat 52 and 78 weeks), 40 mg / kg / day (rabbit 26 weeks) and 10 mg / kg / day (male 52 weeks) detected levels of side effects. There was no target organ for toxicity.

At four studies, intravenous toxicity, which was used ambroxol hydrochloride in rats (dosed 4; 14 and 64 mg / kg / day) and dogs (at doses of 45, 90 and 120 mg / kg / day (infusion 3 hours per day) ) did not show any serious local and systemic toxicity including histopathology. All side effects were reversible.

There were no embryotoxic or teratogenic effects at doses

ambroxol-hydrchloridu to 3000 mg / kg / day in rats and 200 mg / kg / day in rabbits.

Fertility in male and female rats was not damaged at doses up to 500 mg / kg / day.

None known

Store below 30°C.

100mL Pack: 100mL syrup in an amber glass bottle (USP Type III), labelled with a printed label and sealed with gold lacquered PP cap, packed in a printed box along with a measuring cup and a leaflet.

200mL Pack: 200mL syrup in an amber glass bottle (USP Type III), labelled with a printed label and sealed with gold lacquered PP cap, packed in a printed box along with a measuring cup and a leaflet.

No special requirements.