Asta 4

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.

Guaifenesin (Asta 4) and hydrocodone is used to treat cough and reduce chest congestion caused by the common cold, flu, or allergies.

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 (Asta 4) 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.

Guaifenesin (Asta 4) is used to reduce chest congestion caused by the common cold, flu, or chronic bronchitis.

Guaifenesin (Asta 4) helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

There are many brands and forms of Guaifenesin (Asta 4) available. Not all brands are listed on this leaflet.

Guaifenesin (Asta 4) may also be used for purposes not listed in this medication guide.

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 (Asta 4)).

Ambroxol (Asta 4) 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.

ORGANIDIN® NR (Guaifenesin (Asta 4))

Tablets — Adults and children 12 years of age and older: One to 2 tablets (200 mg to 400 mg) every four hours, not to exceed 2400 mg (12 tablets) in 24 hours.

PATIENTS SHOULD BE ADVISED TO KEEP THESE AND ALL DRUGS OUT OF THE REACH OF CHILDREN AND TO SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY IN CASE OF ACCIDENTAL OVERDOSE.

How supplied

ORGANIDIN® NR (Guaifenesin (Asta 4))

Tablets — Each round, scored, rose-colored tablet contains 200 mg Guaifenesin (Asta 4) USP—available in bottles of 100 (NDC 0037-4312-01)

Storage

Store at controlled room temperature 20°-25°C (68°-77°F). Protect tablets from moisture. Keep bottle tightly closed.

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120. Rev. 11/09

See also:
What is the most important information I should know about Ambroxol (Asta 4)?

Hypersensitivity to Ambroxol (Asta 4) hydrochloride or to any other excipients of Ambroxol (Asta 4).

In case of rare hereditary conditions that may be incompatible with an excipient of Ambroxol (Asta 4), the use of Ambroxol (Asta 4) is contraindicated.

Use Ambroxol (Asta 4) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Ambroxol (Asta 4) by mouth with or without food.
• Drink plenty of water while taking Ambroxol (Asta 4).
• If you miss a dose of Ambroxol (Asta 4), 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 (Asta 4).

Use Guaifenesin (Asta 4) sustained-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Guaifenesin (Asta 4) sustained-release tablets by mouth with or without food.
• Drinking extra fluids while you are taking Guaifenesin (Asta 4) sustained-release tablets is recommended. Check with your doctor for instructions.
• Swallow Guaifenesin (Asta 4) sustained-release tablets whole. Do not break, crush, or chew before swallowing.
• If you miss a dose of Guaifenesin (Asta 4) sustained-release tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. 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 Guaifenesin (Asta 4) sustained-release tablets.

Ambroxol (Asta 4) is used to treat certain diseases of the respiratory tract and to relieve cough associated with thickened mucous.

Guaifenesin (Asta 4) is used to treat coughs and congestion caused by the common cold, bronchitis, and other breathing illnesses. This product is usually not used for ongoing cough from smoking or long-term breathing problems (such as chronic bronchitis, emphysema) unless directed by your doctor. Guaifenesin (Asta 4) is an expectorant. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier.

If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.

These products do not cure or shorten the length of the common cold. To decrease the risk for side effects, carefully follow all dosage directions. Do not give other cough-and-cold medication that might contain the same or similar ingredients. Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

How to use 2/G

Take this medication by mouth with or without food, as directed by your doctor, usually every 4 hours. If you are self-treating, follow all directions on the product package. If you are uncertain about any of the information, ask your doctor or pharmacist.

Guaifenesin (Asta 4) may have a bitter taste. Do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

For powder packets, empty the entire contents of the packet onto the tongue and swallow. To prevent a bitter taste, do not chew.

Dosage is based on your age, medical condition, and response to treatment. Do not take more than 6 doses in a day. Do not increase your dose or take this drug more often than directed.

Drink plenty of fluids while taking this medication. Fluids will help to break up mucus and clear congestion.

Tell your doctor if your cough is accompanied by fever, severe sore throat, rash, persistent headache, or if it persists, returns, or worsens after 7 days. These may be signs of a serious medical problem. Seek immediate medical attention if you think you may have a serious medical problem.

See also:
What other drugs will affect Ambroxol (Asta 4)?

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 Guaifenesin (Asta 4)?

In vitro results suggest that methadone undergoes hepatic N-demethylation by cytochrome P450 enzymes, principally CYP3A4, CYP2B6, CYP2C19 and to a lesser extent by CYP2C9 and CYP2D6. Coadministration of methadone with CYP inducers of these enzymes may result in a more rapid metabolism and potential for decreased effects of methadone, whereas administration with CYP inhibitors may reduce metabolism and potentiate methadones effects. Although antiretroviral drugs such as efavirenz, nelfinavir, nevirapine, ritonavir, lopinavir+ritonavir combination are known to inhibit CYPs, they are shown to reduce the plasma levels of methadone, possibly due to their CYP induction activity. Therefore, drugs administered concomitantly with methadone should be evaluated for interaction potential; clinicians are advised to evaluate individual response to drug therapy.

Opioid Antagonists, Mixed Agonist/Antagonists, and Partial Agonists

As with other mu-agonists, patients maintained on methadone may experience withdrawal symptoms when given opioid antagonists, mixed agonist/antagonists, and partial agonists. Examples of such agents are naloxone, naltrexone, pentazocine, nalbuphine, butorphanol, and buprenorphine.

Anti-retroviral Agents

Abacavir, amprenavir, efavirenz, nelfinavir, nevirapine, ritonavir, lopinavir+ritonavir combination - Coadministration of these anti-retroviral agents resulted in increased clearance or decreased plasma levels of methadone. Guaifenesin (Asta 4)-maintained patients beginning treatment with these antiretroviral drugs should be monitored for evidence of withdrawal effects and methadone dose should be adjusted accordingly.

Didanosine and Stavudine - Experimental evidence demonstrated that methadone decreased the AUC and peak levels for didanosine and stavudine, with a more significant decrease for didanosine. Guaifenesin (Asta 4) disposition was not substantially altered.

Zidovudine - Experimental evidence demonstrated that methadone increased the area under the concentration-time curve (AUC) of zidovudine which could result in toxic effects.

Cytochrome P450 Inducers

Guaifenesin (Asta 4)-maintained patients beginning treatment with CYP3A4 inducers should be monitored for evidence of withdrawal effects and methadone dose should be adjusted accordingly. The following drug interactions were reported following coadministration of methadone with inducers of cytochrome P450 enzymes:

Rifampin - In patients well-stabilized on methadone, concomitant administration of rifampin resulted in a marked reduction in serum methadone levels and a concurrent appearance of withdrawal symptoms.

Phenytoin - In a pharmacokinetic study with patients on methadone maintenance therapy, phenytoin administration (250 mg b.i.d. initially for 1 day followed by 300 mg QD for 3 to 4 days) resulted in an approximately 50% reduction in methadone exposure and withdrawal symptoms occurred concurrently. Upon discontinuation of phenytoin, the incidence of withdrawal symptoms decreased and methadone exposure increased to a level comparable to that prior to phenytoin administration.

St. Johns Wort, Phenobarbital, Carbamazepin/strong>Administration of methadone along with other CYP3A4 inducers may result in withdrawal symptoms.

Cytochrome P450 Inhibitors

Since the metabolism of methadone is mediated primarily by CYP3A4 isozyme, coadministration of drugs that inhibit CYP3A4 activity may cause decreased clearance of methadone. The expected clinical results would be increased or prolonged opioid effects. Thus, methadone-treated patients coadministered strong inhibitors of CYP3A4, such as azole antifungal agents (e.g., ketoconazole) and macrolide antibiotics (e.g., erythromycin), with methadone should be carefully monitored and dosage adjustment should be undertaken if warranted. Some selective serotonin reuptake inhibitors (SSRIs) (e.g., sertraline, fluvoxamine) may increase methadone plasma levels upon coadministration with methadone and result in increased opiate effects and/or toxicity.

Voriconazole - Repeat dose administration of oral voriconazole (400mg Q12h for 1 day, then 200mg Q12h for 4 days) increased the Cmax and AUC of (R)-methadone by 31% and 47%, respectively, in subjects receiving a methadone maintenance dose (30 to 100 mg QD). The Cmax and AUC of (S)-methadone increased by 65% and 103%, respectively. Increased plasma concentrations of methadone have been associated with toxicity including QT prolongation. Frequent monitoring for adverse events and toxicity related to methadone is recommended during coadministration. Dose reduction of methadone may be needed.

Others

Monoamine Oxidase (MAO) Inhibitors - Therapeutic doses of meperidine have precipitated severe reactions in patients concurrently receiving monoamine oxidase inhibitors or those who have received such agents within 14 days. Similar reactions thus far have not been reported with methadone. However, if the use of methadone is necessary in such patients, a sensitivity test should be performed in which repeated small, incremental doses of methadone are administered over the course of several hours while the patients condition and vital signs are under careful observation.

Desipramine - Blood levels of desipramine have increased with concurrent methadone administration.

Potentially Arrhythmogenic Agents

Extreme caution is necessary when any drug known to have the potential to prolong the QT interval is prescribed in conjunction with methadone. Pharmacodynamic interactions may occur with concomitant use of methadone and potentially arrhythmogenic agents such as class I and III antiarrhythmics, some neuroleptics and tricyclic antidepressants, and calcium channel blockers.

Caution should also be exercised when prescribing methadone concomitantly with drugs capable of inducing electrolyte disturbances (hypomagnesemia, hypokalemia) that may prolong the QT interval. These drugs include diuretics, laxatives, and, in rare cases, mineralocorticoid hormones.

Interactions with Alcohol and Drugs of Abuse

Guaifenesin (Asta 4) may be expected to have additive effects when used in conjunction with alcohol, other opioids or CNS depressants, or with illicit drugs that cause central nervous system depression. Deaths have been reported when methadone has been abused in conjunction with benzodiazepines.

Anxiety - Since methadone as used by tolerant patients at a constant maintenance dosage does not act as a tranquilizer, patients who are maintained on this drug will react to life problems and stresses with the same symptoms of anxiety as do other individuals. The physician should not confuse such symptoms with those of narcotic abstinence and should not attempt to treat anxiety by increasing the dose of methadone. The action of methadone in maintenance treatment is limited to the control of narcotic withdrawal symptoms and is ineffective for relief of general anxiety.

Acute Pain - Maintenance patients on a stable dose of methadone who experience physical trauma, postoperative pain or other acute pain cannot be expected to derive analgesia from their existing dose of methadone. Such patients should be administered analgesics, including opioids, in doses that would otherwise be indicated for non-methadone-treated patients with similar painful conditions. Due to the opioid tolerance induced by methadone, when opioids are required for management of acute pain in methadone patients, somewhat higher and/or more frequent doses will often be required than would be the case for non-tolerant patients.

Risk of Relapse in Patients on Guaifenesin (Asta 4) Maintenance Treatment of Opioid Addiction

Abrupt opioid discontinuation can lead to development of opioid withdrawal symptoms. Presentation of these symptoms have been associated with an increased risk of susceptible patients to relapse to illicit drug use and should be considered when assessing the risks and benefit of methadone use.

Tolerance and Physical Dependence

Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and/or tolerance are not unusual during chronic opioid therapy.

If methadone is abruptly discontinued in a physically dependent patient, an abstinence syndrome may occur. The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.

In general, chronically administered methadone should not be abruptly discontinued.

Special-Risk Patients

Guaifenesin (Asta 4) should be given with caution and the initial dose reduced in certain patients, such as the elderly and debilitated and those with severe impairment of hepatic or renal function, hypothyroidism, Addisons disease, prostatic hypertrophy, or urethral stricture. The usual precautions appropriate to the use of parenteral opioids should be observed and the possibility of respiratory depression should always be kept in mind.

Guaifenesin (Asta 4) side effects

See also:
What are the possible side effects of Guaifenesin (Asta 4)?

Applies to Guaifenesin (Asta 4): oral capsule, oral capsule extended release, oral elixir, oral liquid, oral packet, oral solution, oral syrup, oral tablet, oral tablet extended release

In addition to its needed effects, some unwanted effects may be caused by Guaifenesin (Asta 4) (the active ingredient contained in Guaifenesin (Asta 4)). In the event that any of these side effects do occur, they may require medical attention.

Minor Side Effects

Some of the side effects that can occur with Guaifenesin (Asta 4) may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common or rare:

• Diarrhea
• dizziness
• headache
• hives
• nausea or vomiting
• skin rash
• stomach pain

Guaifenesin (Asta 4) contraindications

See also:
What is the most important information I should know about Guaifenesin (Asta 4)?

Guaifenesin (Asta 4) is contraindicated in patients with a known hypersensitivity to methadone hydrochloride or any other ingredient in DOLOPHINE.

Guaifenesin (Asta 4) is contraindicated in any situation where opioids are contraindicated such as: patients with respiratory depression (in the absence of resuscitative equipment or in unmonitored settings), and in patients with acute bronchial asthma or hypercarbia.

Guaifenesin (Asta 4) is contraindicated in any patient who has or is suspected of having a paralytic ileus.

What is Terbutaline (Asta 4)?

Terbutaline (Asta 4) injection is used to prevent bronchospasm in patients 12 years of age and older with asthma, bronchitis, emphysema, and other lung diseases.

Terbutaline (Asta 4) belongs to the family of medicines known as bronchodilators. Bronchodilators are medicines that relax the muscles in the bronchial tubes (air passages) of the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

Terbutaline (Asta 4) is available only with your doctor's prescription.

Terbutaline (Asta 4) indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Oral

Acute bronchospasm

Adult: Initially, 2.5 mg or 3 mg tid, up to 5 mg tid as necessary. As modified-release tab: 5 mg or 7.5 mg bid.

Child: <12 yr Initially, 0.05 mg/kg/dose tid, increase gradually as required. Max: 5 mg/day; 12-15 yr 2.5 mg tid; >15 yr Same as adult dose.

Inhalation

Acute bronchospasm

Adult: As metered-dose powd inhaler: 250-500 mcg as required. Max: 2,000 mcg daily.

Parenteral

Severe bronchospasm

Adult: 250-500 mcg up to 4 times daily by SC, IM or IV inj, or by IV infusion as a soln containing 3-5 mcg/mL at a rate of 0.5-1 mL/min.

Child: 2-15 yr 0.01 mg/kg. Max: 0.3 mg/dose.

Reconstitution: Add 10 mL of Terbutaline (Asta 4) soln for inj to 40 mL of dextrose 5% if using a syringe pump or to 490 mL of dextrose 5% if syringe pump is not available.

Intravenous

Uncomplicated premature labour

Adult: To arrest labour between 22-37 wk of gestation: Initially, 5 mcg/min, w/ increments of 2.5 mcg/min at 20 min intervals until contractions stop. Max: 20 mcg/min. Continue for 1 hr after contractions have ceased, then decrease by 2.5 mcg/min every 20 min to lowest dose that maintains suppression. Max duration: 48 hr.

Reconstitution: Add 10 mL of Terbutaline (Asta 4) soln for inj to 40 mL of dextrose 5% if using a syringe pump or to 490 mL of dextrose 5% if syringe pump is not available.

Inhalation

Severe bronchospasm

Adult: As 1% nebuliser soln: 2.5-10 mg 2-4 times daily.

Child: <25 kg: 2-5 mg 2-4 times daily; ≥25 kg: 5 mg 2-4 times daily.

How should I use Terbutaline (Asta 4)?

Use Terbutaline (Asta 4) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Terbutaline (Asta 4) is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Terbutaline (Asta 4) at home, a health care provider will teach you how to use it. Be sure you understand how to use Terbutaline (Asta 4). Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Terbutaline (Asta 4) if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Terbutaline (Asta 4) and are using it regularly, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Terbutaline (Asta 4).

Uses of Terbutaline (Asta 4) in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

Use: Labeled Indications

Asthma/Bronchospasm: Prevention and reversal of bronchospasm in patients ≥12 years of age with asthma and reversible bronchospasm associated with bronchitis and emphysema

Off Label Uses

Extravasation management, sympathomimetic vasoconstrictors

Data from a limited number of patients suggests that Terbutaline (Asta 4) may be beneficial for the management of extravasation of sympathomimetic vasoconstrictors.

Terbutaline (Asta 4) description

Terbutaline (Asta 4) turbuhaler is a breath-activated, multiple-dose powder inhaler free from propellant, lubricant, preservative, carrier substances or other additives.

Terbutaline (Asta 4) injection also contains the following inactive ingredients: Sodium chloride, HCl (for pH adjustment) and water for injections.

Terbutaline (Asta 4) sulphate is 2-(tert-butylamino)-1-(3,5-dihydroxyphenyl)ethanol sulphate.

Terbutaline (Asta 4) dosage

Tablet: Adults: Usual Dose: 1-2 tablets. Children 12-15 years: 1 tablet. All doses to be taken 2-3 times daily.

To be administered at approximately 6-hr intervals. In most patients, the optimum single dose is 2 tablets. In patients unusually sensitive to sympathomimetic amines, initiate treatment with 1 tablet 3 times a day. If adequate bronchodilation is not obtained, the dose may be increased to 2 tablets.

Syrup: Adults and Children >15 years: 10-15 mL (2-3 tsp). Children 7-15 years: 5-10 mL (1-2 tsp); 3-7 years: 2.5-5 mL (½-1 tsp); <3 years: Not recommended. All doses to be taken 3 times a day.

Nebulizing Solution: Terbutaline (Asta 4) nebulizing solution is used with dilution.

Inhale 1 mL of solution containing Terbutaline (Asta 4) sulfate 2.5 mg every 6 hrs (or 4 times in 24-hr period).

If the entire dose is not inhaled at 1 occasion, the solution is stable for 24 hrs in the reservoir of the nebulizer.

Note: The patient's inhalation technique should be checked regularly and the optimal dose of Terbutaline (Asta 4) should be adjusted for each nebulizer. If the effect of the inhalation is reduced, the patient should seek medical care.

Nonselective blocking agents may partly or totally inhibit the effect of β-stimulants.

Directions for Use: 1. Pipette 1 mL of Terbutaline (Asta 4) nebulizing solution from the bottle by using a calibrated medicine dropper provided in the pack, equivalent to Terbutaline (Asta 4) sulfate 2.5 mg.

2. Drop the solution into an electric nebulizer and dilute it with normal saline solution 2 mL and start inhalation.

3. Repeat the same procedure every 6 hrs or 4 times in 24-hr period.

Terbutaline (Asta 4) interactions

See also:
What other drugs will affect Terbutaline (Asta 4)?

Drug Interactions

The concomitant use of Terbutaline (Asta 4) with other sympathomimetic agents is not recommended, since the combined effect on the cardiovascular system may be deleterious to the patient

Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: Terbutaline (Asta 4) should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, since the action of Terbutaline (Asta 4) on the vascular system may be potentiated

Beta-Blockers Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as Terbutaline (Asta 4), but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution

Diuretics The ECG changes and/or hypokalemia that may result from the administration of nonpotassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with nonpotassium-sparing diuretics.

Terbutaline (Asta 4) side effects

See also:
What are the possible side effects of Terbutaline (Asta 4)?

Applies to Terbutaline (Asta 4): oral elixir, oral tablet

Other dosage forms:

• subcutaneous solution

In addition to its needed effects, some unwanted effects may be caused by Terbutaline (Asta 4) (the active ingredient contained in Terbutaline (Asta 4)). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Terbutaline (Asta 4):

More common:

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

Less common:

• Extra heartbeat
• feeling faint, dizzy, or lightheadedness
• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck
• headache
• sweating

Rare

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• excessive muscle tone
• muscle stiffness
• muscle tension or tightness

If any of the following symptoms of overdose occur while taking Terbutaline (Asta 4), get emergency help immediately:

Symptoms of overdose:

• Arm, back, or jaw pain
• blurred vision
• chest pain or discomfort
• chest tightness or heaviness
• confusion
• convulsions
• decreased urine
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fainting
• fast, pounding, or irregular heartbeat or pulse
• general feeling of discomfort or illness
• increased thirst
• loss of appetite
• mood changes
• muscle pain or cramps
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• pounding in the ears
• seizures
• shortness of breath
• sleeplessness
• slow or fast heartbeat
• trouble sleeping
• unable to sleep
• unusual tiredness or weakness

Minor Side Effects

Some of the side effects that can occur with Terbutaline (Asta 4) may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

• Sleepiness or unusual drowsiness

Less common:

• Anxiety
• lack or loss of strength

Rare

• Fever
• rash
• redness, soreness, or itching skin
• seeing, hearing, or feeling things that are not there
• sores, welting, or blisters

Terbutaline (Asta 4) contraindications

See also:
What is the most important information I should know about Terbutaline (Asta 4)?

1.

Prolonged Tocolysis

Terbutaline (Asta 4) sulfate has not been approved for and should not be used for prolonged tocolysis (beyond 48-72 hours). In particular, Terbutaline (Asta 4) sulfate should not be used for maintenance tocolysis in the outpatient or home setting.

2.

Hypersensitivity

Terbutaline (Asta 4) sulfate injection is contraindicated in patients known to be hypersensitive to sympathomimetic amines or any component of this drug product.

See also:
What are the possible side effects of Ambroxol (Asta 4)?

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 (Asta 4)) 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

Each retard capsule contains Ambroxol (Asta 4) hydrochloride 75 mg.

Each tablet contains Ambroxol (Asta 4) hydrochloride 30 mg.

Each 5 mL of syrup contains Ambroxol (Asta 4) hydrochloride 15 or 30 mg.

Each mL of syrup (infant drops) contains Ambroxol (Asta 4) hydrochloride 6 mg.

Ambroxol (Asta 4) 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.

A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of morphine. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Guaifenesin (Asta 4) is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)