Farcosolvin Uses

Rating: 3.3 - 3 review(s)
sponsored
How long did you take this medication to work?

Consists of Ambroxol, Guaifenesin, Theophylline

What is Ambroxol (Farcosolvin)?

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 (Farcosolvin) 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.

Ambroxol (Farcosolvin) 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.
sponsored

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.

How should I use Ambroxol (Farcosolvin)?

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

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

Uses of Ambroxol (Farcosolvin) 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.
sponsored

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

Ambroxol (Farcosolvin) description

Each retard capsule contains Ambroxol (Farcosolvin) hydrochloride 75 mg.

Each tablet contains Ambroxol (Farcosolvin) hydrochloride 30 mg.

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

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

Ambroxol (Farcosolvin) 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.

Ambroxol (Farcosolvin) dosage

sponsored

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 (Farcosolvin)).

Ambroxol (Farcosolvin) 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.

Ambroxol (Farcosolvin) interactions

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

sponsored

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.

Ambroxol (Farcosolvin) side effects

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

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 (Farcosolvin)) 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
Less common:
  • Fast, irregular, pounding, or racing heartbeat or pulse
Rare
  • 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
Incidence not known:
  • 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
Rare
  • Sleepiness
  • unusual drowsiness
Incidence not known:
  • 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

Ambroxol (Farcosolvin) contraindications

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

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

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

What is Guaifenesin (Farcosolvin)?

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

Guaifenesin (Farcosolvin) 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 (Farcosolvin) available. Not all brands are listed on this leaflet.

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

Guaifenesin (Farcosolvin) 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.

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

How should I use Guaifenesin (Farcosolvin)?

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

  • Take Guaifenesin (Farcosolvin) sustained-release tablets by mouth with or without food.
  • Drinking extra fluids while you are taking Guaifenesin (Farcosolvin) sustained-release tablets is recommended. Check with your doctor for instructions.
  • Swallow Guaifenesin (Farcosolvin) sustained-release tablets whole. Do not break, crush, or chew before swallowing.
  • If you miss a dose of Guaifenesin (Farcosolvin) 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 (Farcosolvin) sustained-release tablets.

Uses of Guaifenesin (Farcosolvin) 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.

Guaifenesin (Farcosolvin) 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 (Farcosolvin) 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 (Farcosolvin) 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.

Guaifenesin (Farcosolvin) description

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 (Farcosolvin) 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)

Guaifenesin (Farcosolvin) dosage

ORGANIDIN® NR (Guaifenesin (Farcosolvin))

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 (Farcosolvin))

Tablets — Each round, scored, rose-colored tablet contains 200 mg Guaifenesin (Farcosolvin) 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

Guaifenesin (Farcosolvin) interactions

See also:
What other drugs will affect Guaifenesin (Farcosolvin)?

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 (Farcosolvin)-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 (Farcosolvin) 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 (Farcosolvin)-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 (Farcosolvin) 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 (Farcosolvin) 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 (Farcosolvin) 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 (Farcosolvin) side effects

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

Applies to Guaifenesin (Farcosolvin): 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 (Farcosolvin) (the active ingredient contained in Guaifenesin (Farcosolvin)). 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 (Farcosolvin) 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 (Farcosolvin) contraindications

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

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

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

What is Theophylline (Farcosolvin)?

Theophylline (Farcosolvin) injection is used together with other medicines to treat the acute symptoms of asthma, bronchitis, emphysema, and other lung diseases in a hospital setting.

Theophylline (Farcosolvin) belongs to a group 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.

Theophylline (Farcosolvin) is available only with your doctor's prescription.

Theophylline (Farcosolvin) 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: Patients not taking Theophylline (Farcosolvin) or other xanthine medication: Loading dose: 5 mg/kg.

Child: ≥1 yr Same as adult dose.

Elderly: Lower doses should be used.

Hepatic impairment: Reduce dose.

Oral

Chronic bronchospasm

Adult: 300-1,000 mg in divided doses 6-8 hrly. As modified-release preparation: 175-500 mg 12 hrly.

Child: <6 yr Not recommended; 6-12 yr 20-35 kg: 120-250 mg bid; >12 yr 250-500 mg bid.

Elderly: Lower doses should be used.

Hepatic impairment: Reduce dose.

Intravenous

Acute severe bronchospasm

Adult: Patients not taking Theophylline (Farcosolvin) or other xanthine medication: Loading dose: 4-5 mg/kg by infusion over 20-30 min. Maintenance dose: 0.4-0.6 mg/kg/hr.

Child: Patients not taking Theophylline (Farcosolvin) or other xanthine medication: Loading dose: 4-5 mg/kg by infusion over 20-30 min. Maintenance dose: 1-9 yr Initially, 0.8-1 mg/kg/hr; >9-12 yr Initially, 0.7-0.77 mg/kg/hr.

Elderly: Lower doses should be used.

Hepatic impairment: Reduce dose.

Incompatibility: Y-site: Cefepime, hetastarch in normal saline, phenytoin, ceftazidime. Syringe: Ceftriaxone.

Special Populations: Reduce dose in patients w/ cor pulmonale, heart failure, liver disease and fever. Smokers and those who consume alcohol may require higher maintenance dose.

How should I use Theophylline (Farcosolvin)?

Use Theophylline (Farcosolvin) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Some foods may change the effectiveness or increase the side effects of Theophylline (Farcosolvin). Talk to your doctor about how you should take Theophylline (Farcosolvin) with regard to food. Do not suddenly change your diet or eating habits without first checking with your doctor.
  • Swallow Theophylline (Farcosolvin) whole. Do not break, crush, or chew before swallowing.
  • Take Theophylline (Farcosolvin) at about the same time(s) each day. If you are using more than 1 dose per day, try to take the second dose 10 to 12 hours after your first dose and before the evening meal. Check with your doctor or pharmacist if you have questions about how to take Theophylline (Farcosolvin).
  • If you are using 1 dose per day, take Theophylline (Farcosolvin) in the morning unless your doctor tells you otherwise.
  • Continue to take Theophylline (Farcosolvin) even if you feel well. Do not miss any doses.
  • If you miss a dose of Theophylline (Farcosolvin), 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 Theophylline (Farcosolvin).

Uses of Theophylline (Farcosolvin) 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

Reversible airflow obstruction:

Oral: Treatment of symptoms and reversible airflow obstruction associated with chronic asthma, or other chronic lung diseases (eg, emphysema, chronic bronchitis).

Injection: Treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases (eg, chronic bronchitis, emphysema) as an adjunct to inhaled beta-2 selective agonists and systemically administered corticosteroids. Guideline recommendations:

Guideline recommendations:

Asthma: The 2019 Global Initiative for Asthma Guidelines (GINA) and the 2007 National Heart, Lung and Blood Institute Asthma Guidelines recommends against Theophylline (Farcosolvin) as a long-term control medication for asthma in children ≤5 years of age. Additionally, GINA guidelines do not recommend Theophylline (Farcosolvin) for asthma in children 6 to 11 years of age.

Oral Theophylline (Farcosolvin) is a potential alternative option (not preferred) in adolescents and adults as a long-term control medication in mild asthma or as an add-on long-term control medication in moderate to severe asthma; however, a stepwise approach using inhaled corticosteroids (+/- inhaled long-acting beta agonists depending on asthma severity) is preferred to Theophylline (Farcosolvin) due to efficacy concerns and potential for adverse events (GINA 2019). Both guidelines recommend against Theophylline (Farcosolvin) for the treatment of asthma exacerbations due to poor efficacy and safety concerns (GINA 2019; NAEPP 2007).

COPD: Based on the Global Initiative for Chronic Obstructive Lung Disease Guidelines (2019), use of Theophylline (Farcosolvin) in patients with COPD is controversial and lacks data. Theophylline (Farcosolvin) may favorably impact functional impairment in COPD patients, but exact effects are unclear. Studies that demonstrated improvement were done with slow-release preparations. Theophylline (Farcosolvin) is not a preferred agent for COPD exacerbations due to its potential for toxicity.

Off Label Uses

Bradycardia, heart transplantation

Data from small observational studies suggest that Theophylline (Farcosolvin) may be beneficial for the treatment of bradycardia following heart transplantation.

Theophylline (Farcosolvin) description

Theophylline (Farcosolvin) is a chiral compound. The racemic mixture can be divided into its optical antipodes: levo- and dextro-amphetamine. Theophylline (Farcosolvin) is the parent compound of its own structural class, comprising a broad range of psychoactive derivatives, e.g., MDMA (Ecstasy) and the N-methylated form, methamphetamine. Theophylline (Farcosolvin) is a homologue of phenethylamine.

Theophylline (Farcosolvin) dosage

General Considerations

Theophylline (Farcosolvin) (Theophylline (Farcosolvin) anhydrous capsule) ®, like other extended-release Theophylline (Farcosolvin) products, is intended for patients with relatively continuous or recurring symptoms who have a need to maintain therapeutic serum levels of Theophylline (Farcosolvin). It is not intended for patients experiencing an acute episode of bronchospasm (associated with asthma, chronic bronchitis, or emphysema). Such patients require rapid relief of symptoms and should be treated with an immediate-release or intravenous Theophylline (Farcosolvin) preparation (or other bronchodilators) and not with extended-release products.

Patients who metabolize Theophylline (Farcosolvin) at a normal or slow rate are reasonable candidates for once-daily dosing with Theophylline (Farcosolvin) (Theophylline (Farcosolvin) anhydrous capsule) ®. Patients who metabolize Theophylline (Farcosolvin) rapidly (e.g., the young, smokers, and some nonsmoking adults) and who have symptoms repeatedly at the end of a dosing interval, will require either increased doses given once a day or preferably, are likely to be better controlled by a schedule of twice-daily dosing. Those patients who require increased daily doses are more likely to experience relatively wide peak-trough differences and may be candidates for twice-a-day dosing with Theophylline (Farcosolvin) (Theophylline (Farcosolvin) anhydrous capsule) ®.

Patients should be instructed to take this medication each morning at approximately the same time and not to exceed the prescribed dose.

Recent studies suggest that dosing of extended-release Theophylline (Farcosolvin) products at night (after the evening meal) results in serum concentrations of Theophylline (Farcosolvin) which are not identical to those recorded during waking hours and may be characterized by early trough and delayed peak levels. This appears to occur whether the drug is given as an immediate-release, extended-release, or intravenous product. To avoid this phenomenon when two doses per day are prescribed, it is recommended that the second dose be given 10 to 12 hours after the morning dose and before the evening meal.

Food and posture, along with changes associated with circadian rhythm, may influence the rate of absorption and/or clearance rates of Theophylline (Farcosolvin) from extended-release dosage forms administered at night. The exact relationship of these and other factors to nighttime serum concentrations and the clinical significance of such findings require additional study. Therefore, it is not recommended that

Theophylline (Farcosolvin) (Theophylline (Farcosolvin) anhydrous capsule) ® (when used as a once-a-day product) be administered at night.

Patients who require a relatively high dose of Theophylline (Farcosolvin) (i.e., a dose equal to or greater than 900 mg or 13 mg/kg, whichever is less) should not take Theophylline (Farcosolvin) (Theophylline (Farcosolvin) anhydrous capsule) ® less than 1 hour before a high-fat-content meal since this may result in a significant increase in peak serum level and in the extent of absorption of Theophylline (Farcosolvin) as compared to administration in the fasted state.

The steady-state peak serum Theophylline (Farcosolvin) concentration is a function of the dose, the dosing interval, and the rate of Theophylline (Farcosolvin) absorption and clearance in the individual patient. Because of marked individual differences in the rate of Theophylline (Farcosolvin) clearance, the dose required to achieve a peak serum Theophylline (Farcosolvin) concentration in the 10-20 mcg/mL range varies fourfold among otherwise similar patients in the absence of factors known to alter Theophylline (Farcosolvin) clearance (e.g., 400-1600 mg/day in adults < 60 years old and 10-36 mg/kg/day in children 1-9 years old). For a given population there is no single Theophylline (Farcosolvin) dose that will provide both safe and effective serum concentrations for all patients. Administration of the median Theophylline (Farcosolvin) dose required to achieve a therapeutic serum Theophylline (Farcosolvin) concentration in a given population may result in either sub-therapeutic or potentially toxic serum Theophylline (Farcosolvin) concentrations in individual patients. For example, at a dose of 900 mg/day in adults < 60 years or 22 mg/kg/day in children 1-9 years, the steady-state peak serum Theophylline (Farcosolvin) concentration will be < 10 mcg/mL in about 30% of patients, 10-20 mcg/mL in about 50% and 20-30 mcg/mL in about 20% of patients. The dose of Theophylline (Farcosolvin) must be individualized on the basis of peak serum Theophylline (Farcosolvin) concentration measurements in order to achieve a dose that will provide maximum potential benefit with minimal risk of adverse effects.

Transient caffeine-like adverse effects and excessive serum concentrations in slow metabolizers can be avoided in most patients by starting with a sufficiently low dose and slowly increasing the dose, if judged to be clinically indicated, in small increments. Dose increases should only be made if the previous dosage is well tolerated and at intervals of no less than 3 days to allow serum Theophylline (Farcosolvin) concentrations to reach the new steady state. Dosage adjustment should be guided by serum Theophylline (Farcosolvin) concentration measurement. Health care providers should instruct patients and care givers to discontinue any dosage that causes adverse effects, to withhold the medication until these symptoms are gone and to then resume therapy at a lower, previously tolerated dosage.

If the patient's symptoms are well controlled, there are no apparent adverse effects, and no intervening factors that might alter dosage requirements, serum Theophylline (Farcosolvin) concentrations should be monitored at 6 month intervals for rapidly growing children and at yearly intervals for all others. In acutely ill patients, serum Theophylline (Farcosolvin) concentrations should be monitored at frequent intervals, e.g., every 24 hours.

Theophylline (Farcosolvin) distributes poorly into body fat, therefore, mg/kg dose should be calculated on the basis of ideal body weight. Table V contains Theophylline (Farcosolvin) dosing titration schema recommended for patients in various age groups and clinical circumstances. Table VI contains recommendations for Theophylline (Farcosolvin) dosage adjustment based upon serum Theophylline (Farcosolvin) concentrations. Application of these general dosing recommendations to individual patients must take into account the unique clinical characteristics of each patient. In general, these recommendations should serve as the upper limit for dosage adjustments in order to decrease the risk of potentially serious adverse events associated with unexpected large increases in serum Theophylline (Farcosolvin) concentration.

Table V. Dosing initiation and titration (as anhydrous Theophylline (Farcosolvin)).*

A. Children (12-15 years) and adults (16-60 years) without risk factors for impaired clearance.
Titration Step Children < 45 kg Children > 45 kg and adults
1. Starting Dosage 12-14 mg/kg/day up to a maximum of 300 mg/day divided Q 24 hrs* 300-400 mg/day Dose reduction and/or serum Theophylline (Farcosolvin) concentration measurement is indicated whenever adverse effects are present, physiologic abnormalities that can reduce Theophylline (Farcosolvin) clearance occur (e.g., sustained fever), or a drug that interacts with Theophylline (Farcosolvin) is added or discontinued.

How supplied

Theophylline (Farcosolvin) (Theophylline (Farcosolvin) anhydrous capsule) ® (Theophylline (Farcosolvin) anhydrous) is supplied in extended-release capsules containing 100, 200, 300 or 400 mg of anhydrous Theophylline (Farcosolvin).

Theophylline (Farcosolvin) (Theophylline (Farcosolvin) anhydrous capsule) ® 100 mg capsules are yellow-orange and clear, with markings Theophylline (Farcosolvin) (Theophylline (Farcosolvin) anhydrous capsule), 100 mg, ucb, and 2832, supplied as:

NDC Number Size
50474-100-01 bottle of 100
Theophylline (Farcosolvin)® 200 mg capsules are red-orange and clear, with markings Theophylline (Farcosolvin), 200 mg, ucb, and 2842, supplied as:
NDC Number Size
50474-200-01 bottle of 100
50474-200-50 bottle of 500
Theophylline (Farcosolvin)® 300 mg capsules are red and clear, with markings Theophylline (Farcosolvin), 300 mg, ucb, and 2852, supplied as:
NDC Number Size
50474-300-01 50474-300-50 bottle of 100 bottle of 500
Theophylline (Farcosolvin)® 400 mg capsules are pink and clear, with markings Theophylline (Farcosolvin), 400 mg, ucb, and 2902, supplied as:
NDC Number Size
50474-400-01 bottle of 100

Storage

Store below 77 °F (25 °C).

FOR MEDICAL INFORMATION Contact: Medical Affairs Department Phone: (800) 477-7877, Fax: (770) 970-8859. Manufactured for: UCB Pharma, Inc. Smyrna, GA 30080. by Pfizer Pharmaceuticals LLC Caguas, PR 00725. 04/2005.

Theophylline (Farcosolvin) interactions

See also:
What other drugs will affect Theophylline (Farcosolvin)?

Theophylline (Farcosolvin) interacts with a wide variety of drugs. The interaction may be pharmacodynamic, i.e., alterations in the therapeutic response to Theophylline (Farcosolvin) or another drug or occurrence of adverse effects without a change in serum Theophylline (Farcosolvin) concentration. More frequently, however, the interaction is pharmacokinetic, i.e., the rate of Theophylline (Farcosolvin) clearance is altered by another drug resulting in increased or decreased serum Theophylline (Farcosolvin) concentrations. Theophylline (Farcosolvin) only rarely alters the pharmacokinetics of other drugs.

The drugs listed in Table II have the potential to produce clinically significant pharmacodynamic or pharmacokinetic interactions with Theophylline (Farcosolvin). The information in the “Effect” column of Table II assumes that the interacting drug is being added to a steady-state Theophylline (Farcosolvin) regimen. If Theophylline (Farcosolvin) is being initiated in a patient who is already taking a drug that inhibits Theophylline (Farcosolvin) clearance (e.g., cimetidine, erythromycin), the dose of Theophylline (Farcosolvin) required to achieve a therapeutic serum Theophylline (Farcosolvin) concentration will be smaller. Conversely, if Theophylline (Farcosolvin) is being initiated in a patient who is already taking a drug that enhances Theophylline (Farcosolvin) clearance (e.g., rifampin), the dose of Theophylline (Farcosolvin) required to achieve a therapeutic serum Theophylline (Farcosolvin) concentration will be larger. Discontinuation of a concomitant drug that increases Theophylline (Farcosolvin) clearance will result in accumulation of Theophylline (Farcosolvin) to potentially toxic levels, unless the Theophylline (Farcosolvin) dose is appropriately reduced. Discontinuation of a concomitant drug that inhibits Theophylline (Farcosolvin) clearance will result in decreased serum Theophylline (Farcosolvin) concentrations, unless the Theophylline (Farcosolvin) dose is appropriately increased.

The drugs listed in Table III have either been documented not to interact with Theophylline (Farcosolvin) or do not produce a clinically significant interaction (i.e., < 15% change in Theophylline (Farcosolvin) clearance).

The listing of drugs in Table II and III are current as of February 9, 1995. New interactions are continuously being reported for Theophylline (Farcosolvin), especially with new chemical entities. The clinician should not assume that a drug does not interact with Theophylline (Farcosolvin) if it is not listed in Table II. Before addition of a newly available drug in a patient receiving Theophylline (Farcosolvin), the package insert of the new drug and/or the medical literature should be consulted to determine if an interaction between the new drug and Theophylline (Farcosolvin) has been reported.

Table II: Clinically significant drug interactions with Theophylline (Farcosolvin)*.

Drug Type of Interaction Effect**
Adenosine Theophylline (Farcosolvin) blocks adenosine receptors. Higher doses of adenosine may be required to achieve desired effect.
Alcohol A single large dose of alcohol (3 ml/kg of whiskey) decreases Theophylline (Farcosolvin) clearance for up to 24 hours. 30% increase
Allopurinol Decreases Theophylline (Farcosolvin) clearance at allopurinol doses ≥ 600 mg/day. 25% increase
Amino glutethimide Increases Theophylline (Farcosolvin) clearance by induction of microsomal enzyme activity. 25% decrease
Carbamazepine Similar to aminoglutethimide. 30% decrease
Cimetidine Decreases Theophylline (Farcosolvin) clearance by inhibiting cytochrome P450 1A2. 70% increase
Ciprofloxacin Similar to cimetidine. 40% increase
Clarithromycin Similar to erythromycin. 25% increase
Diazepam Disulfiram Benzodiazepines increase CNS concentrations of adenosine, a potent CNS depressant, while Theophylline (Farcosolvin) blocks adenosine receptors. Decreases Theophylline (Farcosolvin) clearance by inhibiting hydroxylation and demethylation. Larger diazepam doses may be required to produce desired level of sedation. Discontinuation of Theophylline (Farcosolvin) without reduction of diazepam dose may result in respiratory depression. 50% increase
Enoxacin Similar to cimetidine. 300% increase
Ephedrine Synergistic CNS effects Increased frequency of nausea, nervousness, and insomnia.
Erythromycin Erythromycin metabolite decreases Theophylline (Farcosolvin) clearance by inhibiting cytochrome P450 3A3. 35% increase. Erythromycin steady-state serum concentrations decrease by a similar amount.
Estrogen Estrogen containing oral contraceptives decrease Theophylline (Farcosolvin) clearance in a dose- dependent fashion. The effect of progesterone on Theophylline (Farcosolvin) clearance is unknown. 30% increase
Flurazepam Similar to diazepam. Similar to diazepam.
Fluvoxamine Similar to cimetidine Similar to cimetidine
Halothane Halothane sensitizes the myocardium to catecholamines, Theophylline (Farcosolvin) increases release of endogenous catecholamines. Increased risk of ventricular arrhythmias.
Interferon, human recombinant alpha-A Decreases Theophylline (Farcosolvin) clearance. 100% increase
Isoproterenol (IV) Increases Theophylline (Farcosolvin) clearance. 20% decrease
Ketamine Pharmacologic May lower Theophylline (Farcosolvin) seizure threshold.
Lithium Theophylline (Farcosolvin) increases renal lithium clearance. Lithium dose required to achieve a therapeutic serum concentration increased an average of 60%.
Lorazepam Similar to diazepam. Similar to diazepam.
Methotrexate (MTX) Decreases Theophylline (Farcosolvin) clearance. 20% increase after low dose MTX, higher dose MTX may have a greater effect.
Mexiletine Similar to disulfiram. 80% increase
Midazolam Similar to diazepam. Similar to diazepam.
Moricizine Increases Theophylline (Farcosolvin) clearance. 25% decrease
Pancuronium Theophylline (Farcosolvin) may antagonize nondepolarizing neuromuscular blocking effects; possibly due to phosphodiesterase inhibition. Larger dose of pancuronium may be required to achieve neuromuscular blockade.
Pentoxifylline Decreases Theophylline (Farcosolvin) clearance. 30% increase
Phenobarbital (PB) Similar to aminoglutethimide. 25% decrease after two weeks of concurrent PB.
Phenytoin Phenytoin increases Theophylline (Farcosolvin) clearance by increasing microsomal enzyme activity. Theophylline (Farcosolvin) decreases phenytoin absorption. Serum Theophylline (Farcosolvin) and phenytoin concentrations decrease about 40%.
Propafenone Decreases Theophylline (Farcosolvin) clearance and pharmacologic interaction. 40% increase. Beta-2 blocking effect may decrease efficacy of Theophylline (Farcosolvin).
Propranolol Similar to cimetidine and pharmacologic interaction. 100% increase. Beta-2 blocking effect may decrease efficacy of Theophylline (Farcosolvin).
Rifampin Increases Theophylline (Farcosolvin) clearance by increasing cytochrome P450 1A2 and 3A3 activity. 20-40% decrease
Sulfinpyrazone Increases Theophylline (Farcosolvin) clearance by increasing demethylation and hydroxylation. Decreases renal clearanc of Theophylline (Farcosolvin). 20% decrease e
T acrine Similar to cimetidine, also increases renal clearance of Theophylline (Farcosolvin). 90% increase
Thiabendazole Decreases Theophylline (Farcosolvin) clearance. 190% increase
T iclo pidine Decreases Theophylline (Farcosolvin) clearance. 60% increase
Troleandomycin iSimilar to erythromycin. 33-100% increase depending on troleandomycin dose.
Verapamil Similar to disulfiram. 20% increase
*Refer to PRECAUTIONS, Drug Interactions for further information regarding table.

**Average effect on steady state Theophylline (Farcosolvin) concentration or other clinical effect for pharmacologic interactions. Individual patients may experience larger changes in serum Theophylline (Farcosolvin) concentration than the value listed.

Table III. Drugs that have been documented not to interact with Theophylline (Farcosolvin) or drugs that produce no clinically significant interaction with Theophylline (Farcosolvin).*

albuterol, systemic and inhaled felodipinefinasteride nizatidine

norfloxacin

amoxicillin hydrocortisone ofloxacin
ampicillin, with or without isoflurane isoniazid omeprazole prednisone,
sulbactam atenolol isradipine prednisolone ranitidine
azithromycin influenza vaccine rifabutin
caffeine, dietary ingestion ketoconazo lelomefloxacin roxithromycin sorbitol (purgative doses do not inhibit Theophylline (Farcosolvin) absorption)
cefaclor mebendazole
co-trimoxazole (trimethoprim and sulfamethoxazole) medroxyprogesterone

methylprednisolone

diltiazem metronidazole sucralfate
dirithromycin metoprolol terbutaline, systemic
enflurane nadolol terfenadine
famotidine nifedipine tetracycline tocainide
*Refer to PRECAUTIONS: DRUG INTERACTIONS for information regarding table.

The Effect Of Other Drugs On Theophylline (Farcosolvin) Serum Concentration Measurements

Most serum Theophylline (Farcosolvin) assays in clinical use are immunoassays which are specific for Theophylline (Farcosolvin). Other xanthines such as caffeine, dyphylline, and pentoxifylline are not detected by these assays. Some drugs (e.g., cefazolin, cephalothin), however, may interfere with certain HPLC techniques. Caffeine and xanthine metabolites in neonates or patients with renal dysfunction may cause the reading from some dry reagent office methods to be higher than the actual serum Theophylline (Farcosolvin) concentration.

Theophylline (Farcosolvin) side effects

See also:
What are the possible side effects of Theophylline (Farcosolvin)?

Adverse reactions associated with Theophylline (Farcosolvin) are generally mild when peak serum Theophylline (Farcosolvin) concentrations are < 20 mcg/mL and mainly consist of transient caffeine-like adverse effects such as nausea, vomiting, headache, and insomnia. When peak serum Theophylline (Farcosolvin) concentrations exceed 20 mcg/mL, however, Theophylline (Farcosolvin) produces a wide range of adverse reactions including persistent vomiting, cardiac arrhythmias, and intractable seizures which can be lethal. The transient caffeinelike adverse reactions occur in about 50% of patients when Theophylline (Farcosolvin) therapy is initiated at doses higher than recommended initial doses (e.g., > 300 mg/day in adults and > 12 mg/kg/day in children beyond > 1 year of age). During the initiation of Theophylline (Farcosolvin) therapy, caffeine-like adverse effects may transiently alter patient behavior, especially in school age children, but this response rarely persists. Initiation of Theophylline (Farcosolvin) therapy at a low dose with subsequent slow titration to a predetermined age-related maximum dose will significantly reduce the frequency of these transient adverse effects. In a small percentage of patients ( < 3% of children and < 10% of adults) the caffeine-like adverse effects persist during maintenance therapy, even at peak serum Theophylline (Farcosolvin) concentrations within the therapeutic range (i.e., 10-20 mcg/mL). Dosage reduction may alleviate the caffeine-like adverse effects in these patients, however, persistent adverse effects should result in a reevaluation of the need for continued Theophylline (Farcosolvin) therapy and the potential therapeutic benefit of alternative treatment.

Other adverse reactions that have been reported at serum Theophylline (Farcosolvin) concentrations < 20 mcg/mL include diarrhea, irritability, restlessness, fine skeletal muscle tremors, and transient diuresis. In patients with hypoxia secondary to COPD, multifocal atrial tachycardia and flutter have been reported at serum Theophylline (Farcosolvin) concentrations ≥ 15 mcg/mL. There have been a few isolated reports of seizures at serum Theophylline (Farcosolvin) concentrations < 20 mcg/mL in patients with an underlying neurological disease or in elderly patients. The occurrence of seizures in elderly patients with serum Theophylline (Farcosolvin) concentrations < 20 mcg/mL may be secondary to decreased protein binding resulting in a larger proportion of the total serum Theophylline (Farcosolvin) concentration in the pharmacologically active unbound form. The clinical characteristics of the seizures reported in patients with serum Theophylline (Farcosolvin) concentrations < 20 mcg/mL have generally been milder than seizures associated with excessive serum Theophylline (Farcosolvin) concentrations resulting from an overdose (i.e., they have generally been transient, often stopped without anticonvulsant therapy, and did not result in neurological residua).

TABLE IV. Manifestations of Theophylline (Farcosolvin) toxicity. *

Percentage of patients reported with sign or symptom
Acute Overdose

(Large Single Ingestion)

Chronic Overdosage

(Multiple Excessive Doses)

Sign/Symptom Study 1

(n = 157)

Study 2

(n = 14)

Study 1

(n = 92)

Study 2

(n = 102)

Asymptomatic NR** 0 NR** 6
Gastrointestinal
Vomiting 73 93 30 61
Abdominal Pain NR** 21 NR** 12
Diarrhea NR** 0 NR** 14
Hematemesis NR** 0 NR** 2
Metabolic/Other
Hypokalemia 85 79 44 43
Hyperglycemia 98 NR** 18 NR**
Acid/base disturbance 34 21 9 5
Rhabdomyolysis NR** 7 NR** 0
Cardiovascular
Sinus tachycardia 100 86 100 62
Other supraventricular tachycardias 2 21 12 14
Ventricular premature beats 3 21 10 19
Atrial fibrillation or flutter 1 NR** 12 NR**
Multifocal atrial tachycardia 0 NR** 2 NR**
Ventricular arrhythmias with hemodynamic instability 7 14 40 0
Hypotension/shock NR** 21 NR** 8
Neurologic
Nervousness NR** 64 NR** 21
Tremors 38 29 16 14
Disorientation NR** 7 NR** 11
Seizures 5 14 14 5
Death 3 21 10 4
*These data are derived from two studies in patients with serum Theophylline (Farcosolvin) concentrations > 30 mcg/mL. In the first study (Study #1—Shanon, Ann Intern Med 1993;119:1161-67), data were prospectively collected from 249 consecutive cases of Theophylline (Farcosolvin) toxicity referred to a regional poison center for consultation. In the second study (Study #2—Sessler, Am J Med 1990;88:567-76), data were retrospectively collected from 116 cases with serum Theophylline (Farcosolvin) concentrations > 30 mcg/mL among 6000 blood samples obtained for measurement of serum Theophylline (Farcosolvin) concentrations in three emergency departments. Differences in the incidence of manifestations of Theophylline (Farcosolvin) toxicity between the two studies may reflect sample selection as a result of study design (e.g., in Study #1, 48% of the patients had acute intoxications versus only 10% in Study #2) and different methods of reporting results.

**NR = Not reported in a comparable manner.

Theophylline (Farcosolvin) contraindications

See also:
What is the most important information I should know about Theophylline (Farcosolvin)?

Do not take Theophylline (Farcosolvin) in larger or smaller amounts or for longer than recommended. Theophylline (Farcosolvin) overdose can occur if you accidentally take too much at one time, or if your daily doses are too high. To be sure you are using the correct dose, your blood will need to be tested often.

Do not start or stop smoking without first talking to your doctor. Smoking changes the way your body uses Theophylline (Farcosolvin), and you may need to use a different dose.

Sometimes it is not safe to use certain drugs at the same time. Many drugs can interact with Theophylline (Farcosolvin). Tell your doctor about all other medicines you use. Also tell your doctor if you start or stop using any of your other medications.

Stop using Theophylline (Farcosolvin) and call your doctor at once if you have severe or continued vomiting, rapid heartbeats, confusion, tremors, or seizure.

Active ingredient matches for Farcosolvin:

Ambroxol/Guaifenesin/Theophylline in Egypt.


List of Farcosolvin substitutes (brand and generic names)

Sort by popularity
Unit description / dosage (Manufacturer)Price, USD

References

  1. DailyMed. "THEOPHYLLINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DailyMed. "GUAIFENESIN; HYDROCODONE BITARTRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  3. PubChem. "guaifenesin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Farcosolvin are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Farcosolvin. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

2 consumers reported useful

Was the Farcosolvin drug useful in terms of decreasing the symptom or the disease?
According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
Users%
Useful2
100.0%


1 consumer reported price estimates

Was the price you paid to purchase the drug reasonable? Did you feel it was expensive?
The below mentioned numbers have been reported by ndrugs.com website users about whether the Farcosolvin drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
Users%
Not expensive1
100.0%


3 consumers reported time for results

To what extent do I have to use Farcosolvin before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes 1 day and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Farcosolvin. To get the time effectiveness of using Farcosolvin drug by other patients, please click here.
Users%
1 day2
66.7%
> 3 month1
33.3%


6 consumers reported age

Users%
< 12
33.3%
46-601
16.7%
16-291
16.7%
1-51
16.7%
30-451
16.7%


Consumer reviews


There are no reviews yet. Be the first to write one!


Your name: 
Email: 
Spam protection:  < Type 26 here

Information checked by Dr. Sachin Kumar, MD Pharmacology

| Privacy Policy
This site does not supply any medicines. It contains prices for information purposes only.
© 2003 - 2020 ndrugs.com All Rights Reserved