Ambroxol/Benzonatate

For use Max Pidek Pharmaceuticals as monotherapy and in combination with clavulanic acid: an infectious-inflammatory diseases caused by susceptible microorganisms, including bronchitis, pneumonia, tonsillitis, pyelonephritis, urethritis, infections of the gastrointestinal tract, gynecological infections, infections of the skin and soft tissue, listeria, leptospirosis, gonorrhea.

For use Max Pidek Pharmaceuticals in combination with metronidazole: chronic gastritis in acute, peptic ulcer and duodenal ulcer in acute, associated with Helicobacter Pylori.

Benzonatate is a medication taken orally to suppress coughs. It has an anesthetic (numbing) action similar to that of benzocaine and "numbs" the stretch sensors in the lungs. It is the stretching of these sensors with breathing that causes the cough. Benzonatate begins to work within 15 to 20 minutes, and its effects last for approximately 3 hours. Benzonatate is unrelated to narcotics such as codeine which are frequently used to suppress coughs. (Another frequently used cough suppressant, dextromethorphan, which is found in many over-the-counter cough and cold preparations, is a derivative of the narcotics.) Benzonatate was approved by the FDA in 1958.

Relieving cough and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Ambroxol is a cough suppressant and expectorant combination. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough. The expectorant works by loosening mucus and lung secretions in the chest and making coughs more productive.

Benzonatate is used to relieve coughs due to colds or influenza (flu). It is not to be used for chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm with the cough.

Benzonatate relieves cough by acting directly on the lungs and the breathing passages. It may also act on the cough center in the brain.

benzonatate is available only with your doctor's prescription.

Sustained-Release Capsule: Adults and Children >12 years: 1 cap once daily after meal with plenty of liquid (sufficient supply of liquid supports the expectorant effect of Ambroxol).

Ambroxol SR capsule is not suitable for children <12 years.

Tablet: Adults and Children >12 years: 1 tab thrice daily for the first 2-3 days and then 1 tab twice daily or ½ tab thrice daily. Children 6-12 years: ½ tab 2-3 times a day.

Syrup: Adults and Children >12 years: 10 mL thrice daily during the first 2-3 days, them 10 mL twice daily or 5 mL thrice daily. Children 6-12 years: 5 mL 2-3 times a day; 2-5 years: 2.5 mL 3 times a day; <2 years: 2.5 mL 2 times a day.

DS Syrup: Adults and Children >12 years: 5 mL thrice daily for 2-3 days then 5 mL twice daily for 2.5 mL thrice daily. Children 6-12 years: 2.5 mL 2-3 times a day.

Infant Drops: Children 13-24 months: 1.25 mL twice a day; 7-12 months: 1 mL twice a day; ≤6 months: 0.5 mL twice a day.

Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate Capsules should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.

How supplied

Benzonatate capsules USP, 100 mg are light yellow-colored, round-shaped soft gelatin capsules, imprinted with “Z” containing pale yellow-colored clear viscous liquid and are supplied as follows:

NDC 65841-614-01 in bottle of 100 capsules

NDC 65841-614-05 in bottle of 500 capsules

Benzonatate capsules USP, 200 mg are light yellow-colored, round-shaped soft gelatin capsules, imprinted with “β” containing pale yellow-colored clear viscous liquid and are supplied as follows:

NDC 65841-615-01 in bottle of 100 capsules

Store at 20° - 25°C (68° - 77°F).

Dispense in a tight, light-resistant container.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Revised: 11/03/2011

See also:
What is the most important information I should know about Ambroxol?

Hypersensitivity to ambroxol hydrochloride or to any other excipients of Ambroxol.

In case of rare hereditary conditions that may be incompatible with an excipient of Ambroxol, the use of Ambroxol is contraindicated.

See also:
What is the most important information I should know about Benzonatate?

You should not use this medication if you are allergic to benzonatate or topical numbing medicines such as tetracaine or procaine (found in some insect bite and sunburn creams).

Never suck or chew on a benzonatate capsule. Swallow the pill whole. Sucking or chewing the capsule may cause your mouth and throat to feel numb or cause other serious side effects.

Serious side effects of benzonatate include choking feeling, chest pain or numbness, feeling like you might pass out, confusion, or hallucinations. Some of these side effects may result from chewing or sucking on a benzonatate capsule.

Do not give this medication to a child younger than 10 years old without medical advice. An overdose of benzonatate can be fatal to a child.

Use Ambroxol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Ambroxol by mouth with or without food.
• Drink plenty of water while taking Ambroxol.
• If you miss a dose of Ambroxol, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ambroxol.

Use Benzonatate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Benzonatate by mouth with or without food.
• Swallow Benzonatate whole. Do not break, crush, chew, dissolve, or suck on Benzonatate before swallowing.
• If you miss a dose of Benzonatate, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Benzonatate.

Ambroxol is used to treat certain diseases of the respiratory tract and to relieve cough associated with thickened mucous.

Use: Labeled Indications

Cough: Symptomatic relief of cough

See also:
What other drugs will affect Ambroxol?

Amoxicillin may decrease the effectiveness of contraceptives for oral administration.

With the simultaneous use of Max Pidek Pharmaceuticals with bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) appears synergies; with bacteriostatic antibiotic (including macrolides, chloramphenicol, lincosamides, tetracyclines, sulphonamide) - antagonism.

Amoxicillin increases the effects of indirect anticoagulants inhibiting intestinal microflora, reduces the synthesis of vitamin K and prothrombin index.

Amoxicillin reduces the effect of drugs, in the process of metabolism that produce PABA.

Probenecid, diuretics, allopurinol, phenylbutazone, NSAIDs decrease the tubular secretion of amoxicillin, which can be accompanied by an increase in its concentration in blood plasma.

Antacids, glucosamine, laxatives, aminoglycosides, slow down and reduce, and ascorbic acid increases the absorption of amoxicillin.

With the combined use of amoxicillin and clavulanic acid pharmacokinetics of both components unchanged.

See also:
What other drugs will affect Benzonatate?

There are no known drug interactions with benzonatate.

See also:
What are the possible side effects of Ambroxol?

Applies to albuterol: oral syrup, oral tablet, oral tablet extended release

Other dosage forms:

• inhalation aerosol powder, inhalation capsule, inhalation powder, inhalation solution

As well as its needed effects, albuterol (the active ingredient contained in Ambroxol) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking albuterol, check with your doctor immediately:

More common:

• Shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet

• Fast, irregular, pounding, or racing heartbeat or pulse

• Cough
• difficulty breathing
• difficulty with swallowing
• hives or welts
• hoarseness
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• redness of the skin
• shortness of breath
• skin rash
• slow or irregular breathing
• swelling of the mouth or throat
• tightness in the chest
• wheezing

• Agitation
• anxiety
• arm, back, or jaw pain
• blurred vision
• chest pain or discomfort
• confusion
• convulsions
• extra heartbeats
• fainting
• hallucinations
• headache
• irritability
• lightheadedness
• mood or mental changes
• muscle pain or cramps
• muscle spasm or jerking of all extremities
• nervousness
• nightmares
• pounding in the ears
• restlessness
• sudden loss of consciousness
• sweating
• total body jerking
• unusual feeling of excitement
• vomiting

Minor Side Effects

Some albuterol side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common:

• Dizziness
• feeling of warmth
• irritability
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• sleeplessness
• trouble with holding or releasing urine
• trouble sleeping
• unable to sleep

• Sleepiness
• unusual drowsiness

• Bad, unusual, or unpleasant (after) taste
• change in taste
• feeling of constant movement of self or surroundings
• gagging
• rough, scratchy sound to voice
• sensation of spinning
• tightness in the throat

See also:
What are the possible side effects of Benzonatate?

Applies to benzonatate: oral capsule, oral capsule liquid filled

As well as its needed effects, benzonatate (the active ingredient contained in Benzonatate) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking benzonatate, check with your doctor immediately:

Rare

• Confusion
• difficult breathing
• difficulty with speaking
• seeing things that are not there
• shortness of breath
• tightness in the chest
• wheezing

If any of the following symptoms of overdose occur while taking benzonatate, get emergency help immediately:

Symptoms of overdose:

• Change in consciousness
• convulsions (seizures)
• loss of consciousness
• no blood pressure or pulse
• restlessness
• shakiness in the legs, arms, hands, or feet
• stopping of the heart
• trembling or shaking of the hands or feet
• unconsciousness

Minor Side Effects

Some benzonatate side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common or rare:

• Burning sensation in the eyes
• constipation
• dizziness (mild)
• drowsiness (mild)
• headache
• itching
• nausea or vomiting
• skin rash
• stuffy nose

Each retard capsule contains ambroxol hydrochloride 75 mg.

Each tablet contains ambroxol hydrochloride 30 mg.

Each 5 mL of syrup contains ambroxol hydrochloride 15 or 30 mg.

Each mL of syrup (infant drops) contains ambroxol hydrochloride 6 mg.

Ambroxol hydrochloride is trans-4-[(2-amino-3,5-dibromo-benzyl)amino] cyclohexanol hydrochloride.

It also contains the following excipients: Retard Capsules: Crospovidone collidon CL, carnauba wax, stearyl alcohol, magnesium stearate.

Tablets: Lactose, maize starch, colloidal silica, magnesium stearate.

Syrup: Purified water, sorbitol liquid, glycerol 85%, woodberry aroma (15 mg only), strawberry aroma (30 mg only), hydroxyethylcellulose, benzoic acid, acesulfame potassium, vanilla aroma.

Infant Drops: Hydroxyethylcellulose, sorbitol solution, glycerol 85%, sodium saccharin, pharma flavors, menthol, benzoic acid, propylene glycol.

Benzonatate is a non-narcotic oral antitussive (cough suppressant) drug which works by anesthetizing the tissues of the lungs and pleura responsible for the cough reflex. It is chemically related to other ester anesthetics such as procaine. It has an anesthetic (numbing) action similar to that of benzocaine and "numbs" the stretch sensors in the lungs. It is the stretching of these sensors with breathing that causes the cough. It was approved by the FDA in 1958