Ambroxol/Chlorpheniramine/Guaifenesin/Menthol/Phenylephrine Uses

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Consists of Ambroxol, Chlorpheniramine, Guaifenesin, Menthol, Phenylephrine

What is Ambroxol?

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

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

Ambroxol indications

infoAn 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.
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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?

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

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

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

Uses of Ambroxol in details

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

Ambroxol description

Each retard capsule contains ambroxol hydrochloride 75 mg.

Each tablet contains ambroxol hydrochloride 30 mg.

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

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

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

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

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

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

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

Ambroxol dosage

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

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

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

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

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

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

Ambroxol interactions

See also:
What other drugs will affect Ambroxol?

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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 side effects

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

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

Other dosage forms:

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

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

Major Side Effects

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

More common:

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

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

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

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

What is Chlorpheniramine?

Chlorpheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Chlorpheniramine is used to treat runny nose, sneezing, itching, and watery eyes caused by allergies, the common cold, or the flu.

Chlorpheniramine may also be used for purposes not listed in this medication guide.

Chlorpheniramine indications

infoAn 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.

this medicine is indicated for symptomatic control of all allergic conditions responsive to antihistamines, including hay fever, vasomotor rhinitis, urticaria, angioneurotic oedema, food allergy, drug and serum reactions, insect bites.

Also indicated for the symptomatic relief of itch associated with chickenpox

How should I use Chlorpheniramine?

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

  • Chlorpheniramine may be taken with or without food.
  • Shake well before using.
  • Use the dropper that comes with Chlorpheniramine to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • If you miss a dose of Chlorpheniramine, 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 Chlorpheniramine.

Uses of Chlorpheniramine in details

infoThere 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.

Chlorpheniramine is used to relieve symptoms of runny nose, sneezing, itching, and watery eyes caused by allergies, the common cold, or the flu and allergies due to food and insect bites and hay fever.

Chlorpheniramine description

A histamine H1 antagonist used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than promethazine.

Chlorpheniramine dosage

Usual Adult Dose for Allergic Rhinitis:

Tablets or syrup: 4 mg orally every 4 to 6 hours.

Sustained-release: 8 to 16 mg orally every 8 to 12 hours as needed or 16 mg orally once a day as needed.

Maximum dose 32 mg/day.

Usual Adult Dose for Cold Symptoms:

Tablets or syrup: 4 mg orally every 4 to 6 hours.

Sustained-release: 8 to 16 mg orally every 8 to 12 hours as needed or 16 mg orally once a day as needed.

Maximum dose 32 mg/day.

Usual Adult Dose for Urticaria:

Tablets or syrup: 4 mg orally every 4 to 6 hours.

Sustained-release: 8 to 16 mg orally every 8 to 12 hours as needed or 16 mg orally once a day as needed.

Maximum dose 32 mg/day.

Usual Adult Dose for Allergic Reaction:

Injectable solution:

Allergic reactions to blood or plasma infusions: 10 to 20 mg by intravenous, intramuscular, or subcutaneous injection as a single dose.

Anaphylaxis: 10 to 20 mg intravenous injection as a single dose.

Uncomplicated Allergic Conditions: 5 to 20 mg by intravenous, intramuscular, or subcutaneous injection as a single dose.

Maximum dose by injection is 40 mg/day.

Tablets or syrup: 4 mg orally every 4 to 6 hours.

Sustained-release: 8 to 16 mg orally every 8 to 12 hours as needed or 16 mg orally once a day as needed.

Maximum dose 32 mg/day.

Usual Pediatric Dose for Allergic Rhinitis:

3 months to 5 months:

Sustained-release syrup: 0.5 mg orally every 12 hours.

6 months to 8 months:

Sustained-release syrup: 1 mg orally every 12 hours.

9 months to 18 months:

Sustained-release syrup: 1 to 1.5 mg orally every 12 hours.

18 months to 6 years:

Sustained-release syrup: 2 mg orally every 12 hours.

2 to 5 years:

Tablets or syrup: 1 mg every 4 to 6 hours.

Sustained-release: 2 mg orally two times a day, not to exceed 8 mg in 24 hours.

Maximum dose 6 mg/day.

6 to 11 years:

Tablets or syrup: 2 mg every 4 to 6 hours.

Sustained-release: 4 to 8 mg orally two times a day, not to exceed 16 mg in 24 hours or 8 mg orally at bedtime or during the day as indicated.

Maximum dose 16 mg/day.

12 years or older:

Tablets or syrup: 4 mg orally every 4 to 6 hours.

Sustained-release: 8 to 16 mg orally every 8 to 12 hours as needed or 16 mg orally once a day as needed

Maximum dose 32 mg/day.

Usual Pediatric Dose for Cold Symptoms:

3 months to 5 months:

Sustained-release syrup: 0.5 mg orally every 12 hours.

6 months to 8 months:

Sustained-release syrup: 1 mg orally every 12 hours.

9 months to 18 months:

Sustained-release syrup: 1 to 1.5 mg orally every 12 hours.

18 months to 6 years:

Sustained-release syrup: 2 mg orally every 12 hours.

2 to 5 years:

Tablets or syrup: 1 mg every 4 to 6 hours.

Sustained-release: 2 mg orally two times a day, not to exceed 8 mg in 24 hours.

Maximum dose 6 mg/day.

6 to 11 years:

Tablets or syrup: 2 mg every 4 to 6 hours.

Sustained-release: 4 to 8 mg orally two times a day, not to exceed 16 mg in 24 hours or 8 mg orally at bedtime or during the day as indicated.

Maximum dose 16 mg/day.

12 years or older:

Tablets or syrup: 4 mg orally every 4 to 6 hours.

Sustained-release: 8 to 16 mg orally every 8 to 12 hours as needed or 16 mg orally once a day as needed

Maximum dose 32 mg/day.

Usual Pediatric Dose for Urticaria:

3 months to 5 months:

Sustained-release syrup: 0.5 mg orally every 12 hours.

6 months to 8 months:

Sustained-release syrup: 1 mg orally every 12 hours.

9 months to 18 months:

Sustained-release syrup: 1 to 1.5 mg orally every 12 hours.

18 months to 6 years:

Sustained-release syrup: 2 mg orally every 12 hours.

2 to 5 years:

Tablets or syrup: 1 mg every 4 to 6 hours.

Sustained-release: 2 mg orally two times a day, not to exceed 8 mg in 24 hours.

Maximum dose 6 mg/day.

6 to 11 years:

Tablets or syrup: 2 mg every 4 to 6 hours.

Sustained-release: 4 to 8 mg orally two times a day, not to exceed 16 mg in 24 hours or 8 mg orally at bedtime or during the day as indicated.

Maximum dose 16 mg/day.

12 years or older:

Tablets or syrup: 4 mg orally every 4 to 6 hours.

Sustained-release: 8 to 16 mg orally every 8 to 12 hours as needed or 16 mg orally once a day as needed

Maximum dose 32 mg/day.

Usual Pediatric Dose for Allergic Reaction:

Injectable solution:

2 years to 11 years: 0.35 mg/kg/day in divided doses every 4 to 6 hours as needed.

12 years or older:

Allergic reactions to blood or plasma infusions: 10 to 20 mg by intravenous, intramuscular, or subcutaneous injection as a single dose.

Anaphylaxis: 10 to 20 mg intravenous injection as a single dose.

Uncomplicated Allergic Conditions: 5 to 20 mg by intravenous, intramuscular, or subcutaneous injection as a single dose.

Maximum dose by injection is 40 mg/day.

Tablets or syrup:

2 to 5 years: 1 mg every 4 to 6 hours.

Maximum dose 6 mg/day.

Sustained-release: 2 mg orally two times a day, not to exceed 8 mg in 24 hours.

6 to 11 years: 2 mg every 4 to 6 hours.

Sustained-release: 4 to 8 mg orally two times a day, not to exceed 16 mg in 24 hours or 8 mg at bedtime or during the day as indicated.

Maximum dose 16 mg/day.

12 years or older: 4 mg orally every 4 to 6 hours.

Sustained-release: 8 to 16 mg orally every 8 to 12 hours as needed or 16 mg orally once a day as needed

Maximum dose 32 mg/day.

Chlorpheniramine interactions

See also:
What other drugs will affect Chlorpheniramine?

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray), antispasmodics (e.g., atropine, belladonna alkaloids), drugs for Parkinson's disease (e.g., anticholinergics such as benztropine, trihexyphenidyl), scopolamine, tricyclic antidepressants (e.g., amitriptyline).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

Chlorpheniramine is very similar to dexchlorpheniramine. Do not use medications containing dexchlorpheniramine while using chlorpheniramine.

This medication may interfere with certain laboratory tests (including allergy skin testing), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Chlorpheniramine side effects

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

Applies to chlorpheniramine: capsules, controlled-release capsules, suspension drops, sustained-release capsules, syrup, tablets

Other dosage forms:

  • suspension

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur while taking chlorpheniramine (the active ingredient contained in Chlorpheniramine (Allergy))

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.

Chlorpheniramine contraindications

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

Hypersensitivity to chlorpheniramine maleate or any component of the formulation; narrow-angle glaucoma; bladder neck obstruction; symptomatic prostate hypertrophy; during acute asthmatic attacks; stenosing peptic ulcer; pyloroduodenal obstruction. Avoid use in premature and term newborns due to possible association with SIDS.

What is Guaifenesin?

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

Guaifenesin 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 available. Not all brands are listed on this leaflet.

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

Guaifenesin indications

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

How should I use Guaifenesin?

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

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

Uses of Guaifenesin in details

infoThere 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 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 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 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 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 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 dosage

ORGANIDIN® NR (guaifenesin)

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)

Tablets — Each round, scored, rose-colored tablet contains 200 mg guaifenesin 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 interactions

See also:
What other drugs will affect Guaifenesin?

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-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 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-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 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 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 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 side effects

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

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

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

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

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

What is Menthol?

Relieving minor pain caused by conditions such as arthritis, backache, bruising, bursitis, cramping, muscle strains or sprains, and tendonitis. It may also be used for other conditions as determined by your doctor.

Menthol is a topical analgesic. It works by temporarily relieving minor pain.

Menthol indications

infoAn 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

Nasal congestion; Throat irritation

Adult: As a loz (usually in combination with eucalyptus oil or cetylpyridinium chloride): 1 loz every 3 hr, to be sucked slowly.

Child: >6 yr: As a lozenge (usually in combination with eucalyptus oil or cetylpyridinium chloride): 1 lozenge every 3 hr, to be sucked slowly.

Topical/Cutaneous

Muscular aches and pains

Adult: As an ointment/cream (usually in combination with camphor, clove oil or methyl salicylate): Apply and rub gently onto the affected skin areas 2-3 times daily.

How should I use Menthol?

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

  • Wash your hands before and right after using Menthol.
  • Spray Menthol directly onto the affected area. Do not rub or massage the medicine into the skin.
  • Do not wrap, bandage, or use a heating pad on the treated area.
  • Do not apply Menthol more than 4 times daily.
  • If you miss a dose of Menthol, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

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

Uses of Menthol in details

infoThere 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.

Pharmaceutical Aid

Menthol description

Menthol is a covalent organic compound made synthetically or obtained from peppermint or other mint oils. It is a waxy, crystalline substance, clear or white in color, which is solid at room temperature and melts slightly above. The main form of menthol occurring in nature is (-)-menthol, which is assigned the (1R,2S,5R) configuration. Menthol has local anesthetic and counterirritant qualities, and it is widely used to relieve minor throat irritation.

Menthol dosage

Oral

Nasal congestion; Throat irritation

Adult: As a loz (usually in combination with eucalyptus oil or cetylpyridinium chloride): 1 loz every 3 hr, to be sucked slowly.

Child: >6 yr: As a lozenge (usually in combination with eucalyptus oil or cetylpyridinium chloride): 1 lozenge every 3 hr, to be sucked slowly.

Topical/Cutaneous

Muscular aches and pains

Adult: As an ointment/cream (usually in combination with camphor, clove oil or methyl salicylate): Apply and rub gently onto the affected skin areas 2-3 times daily.

Menthol interactions

Tell your doctor of any over-the-counter or prescription medication you may take including: blood thinners.

Do not start or stop any medicine without doctor or pharmacist approval.

Menthol side effects

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

May cause hypersensitivity reactions such as cutaneous dermatitis. Ingestion of large amount of menthol may cause GI effects such as severe abdominal pain, nausea, vomiting, vertigo, ataxia, drowsiness and coma.

Menthol contraindications

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

Not to be used in

No known conditions.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

What is Phenylephrine?

Phenylephrine ophthalmic causes constriction of blood vessels in the eyes. It also enlarges the pupils, reduces the production of fluid in the eyes, and increases the amount of fluid that drains from the eyes.

Phenylephrine ophthalmic available over-the-counter is used to relieve redness, burning, irritation, and dryness of the eye caused by wind, sun, and other minor irritants. Prescription-strength phenylephrine ophthalmic is used to constrict blood vessels in the eye and to dilate (make bigger) the pupil for conditions such as glaucoma, before surgery, and before eye examinations.

Phenylephrine ophthalmic may also be used for purposes other than those listed in this medication guide.

Phenylephrine indications

infoAn 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.

Phenylephrine is used for the temporary relief of stuffy nose, sinus, and ear symptoms caused by the common cold, flu, allergies, or other breathing illnesses (e.g., sinusitis, bronchitis). This medication works by decreasing swelling in the nose and ears, thereby lessening discomfort and making it easier to breathe.

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.

How should I use Phenylephrine?

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

  • Phenylephrine is for use in the eye only. Avoid contact with the nose or mouth.
  • To use Phenylephrine, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
  • To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including your eye. Keep the container tightly closed.
  • Do not wear contact lenses while you are using Phenylephrine. Sterilize contact lenses according to the manufacturer's directions and check with your doctor before using them.
  • Do not use Phenylephrine if it is brown or contains particles.
  • If you miss a dose of Phenylephrine, 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 Phenylephrine.

Uses of Phenylephrine in details

infoThere 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.

This combination medication is used to temporarily treat cough and runny/stuffy nose (nasal congestion) caused by infections (such as the common cold), allergies (such as hay fever), 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. Phenylephrine is an expectorant. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier. Phenylephrine is a decongestant (sympathomimetic). It reduces nasal congestion by narrowing the blood vessels in the nose.

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 and may cause serious side effects. To decrease the risk for serious 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 Phenylephrine

Take this medication by mouth with or without food, as directed by your doctor. If you are self-treating, follow all directions on the product package. To prevent trouble sleeping, do not take this medication close to bedtime. If you are uncertain about any of the information, ask your doctor or pharmacist.

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

Phenylephrine may have a bitter taste. Swallow capsules and tablets whole. Scored tablets may be split for lower doses. Chewable tablets may be swallowed whole or chewed.

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

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. If your liquid form is a suspension, shake the bottle well before each dose.

Tell your doctor if your condition 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.

Phenylephrine description

Phenylephrine is a sympathomimetic amine that acts predominantly on α-adrenergic receptors. It is mainly used to treat nasal congestion, but may also be useful in treating hypotension and shock, hypotension during spinal anaesthesia, prolongation of spinal anaesthesia, paroxysmal supraventricular tachycardia, symptomatic relief of external or internal hemorrhoids, and to increase blood pressure as an aid in the diagnosis of heart murmurs.

Phenylephrine dosage

Prolonged exposure to air or strong light may cause oxidation and discoloration. Do not use if solution is brown or contains a precipitate.

Vasoconstriction and Pupil Dilatation

Phenylephrine (phenylephrine hydrochloride ophthalmic solution) hydrochloride 10 percent ophthalmic solutions are especially useful when rapid and powerful dilatation of the pupil and reduction of congestion in the capillary bed are desired. A drop of a suitable topical anesthetic may be applied, followed in a few minutes by 1 drop of the Phenylephrine (phenylephrine hydrochloride ophthalmic solution) hydrochloride 10 percent ophthalmic solutions on the upper limbus. The anesthetic prevents stinging and consequent dilution of the solution by lacrimation. It may occasionally be necessary to repeat the instillation after one hour, again preceded by the use of the topical anesthetic.

Uveitis: Posterior Synechiae

Phenylephrine (phenylephrine hydrochloride ophthalmic solution) hydrochloride 10 percent ophthalmic solutions may be used in patients with uveitis when synechiae are present or may develop. The formation of synechiae may be prevented by the use of the 10 percent ophthalmic solutions and atropine to produce wide dilatation of the pupil. It should be emphasized, however, that the vasoconstrictor effect of Phenylephrine (phenylephrine hydrochloride ophthalmic solution) hydrochloride may be antagonistic to the increase of local blood flow in uveal infection.

To free recently formed posterior synechiae, 1 drop of the 10 percent ophthalmic solutions may be applied to the upper surface of the cornea. On the following day, treatment may be continued if necessary. In the interim, hot compresses should be applied for five or ten minutes three times a day, with 1 drop of a 1 or 2 percent solution of atropine sulfate before and after each series of compresses.

Glaucoma

In certain patients with glaucoma, temporary reduction of intraocular tension may be attained by producing vasoconstriction of the intraocular vessels; this may be accomplished by placing 1 drop of the 10 percent ophthalmic solutions on the upper surface of the cornea. This treatment may be repeated as often as necessary.

Phenylephrine (phenylephrine hydrochloride ophthalmic solution) hydrochloride may be used with miotics in patients with wide angle glaucoma. It reduces the difficulties experienced by the patient because of the small field produced by miosis, and still it permits and often supports the effect of the miotic in lowering the intraocular pressure. Hence, there may be marked improvement in visual acuity after using Phenylephrine (phenylephrine hydrochloride ophthalmic solution) hydrochloride in conjunction with miotic drugs.

Surgery

When a short-acting mydriatic is needed for wide dilatation of the pupil before intraocular surgery, the 10 percent ophthalmic solutions or 2.5 percent ophthalmic solution may be applied topically from 30 to 60 minutes before the operation.

Refraction

Prior to determination of refractive errors, Phenylephrine (phenylephrine hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution may be used effectively with homatropine hydrobromide, atropine sulfate, or a combination of homatropine and cocaine hydrochloride.

For adults, a drop of the preferred cycloplegic is placed in each eye, followed in five minutes by 1 drop of Phenylephrine (phenylephrine hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution and in ten minutes by another drop of the cycloplegic. In 50 to 60 minutes, the eyes are ready for refraction.

For children, a drop of atropine sulfate 1 percent is placed in each eye, followed in 10 to 15 minutes by 1 drop of Phenylephrine (phenylephrine hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution and in five to ten minutes by a second drop of atropine sulfate 1 percent. In one to two hours, the eyes are ready for refraction.

For a “one application method,” Phenylephrine (phenylephrine hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution may be combined with a cycloplegic to elicit synergistic action. The additive effect varies depending on the patient. Therefore, when using a “one application method,” it may be desirable to increase the concentration of the cycloplegic.

Ophthalmoscopic Examination

One drop of Phenylephrine (phenylephrine hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution is placed in each eye. Sufficient mydriasis to permit examination is produced in 15 to 30 minutes. Dilatation lasts from one to three hours.

Diagnostic Procedures

Provocative Test for Angle Block in Patients with Glaucoma: The 2.5 percent ophthalmic solution may be used as a provocative test when latent increased intraocular pressure is suspected. Tension is measured before application of Phenylephrine (phenylephrine hydrochloride ophthalmic solution) hydrochloride and again after dilatation. A 3 to 5 mm of mercury rise in pressure suggests the presence of angle block in patients with glaucoma; however, failure to obtain such a rise does not preclude the presence of glaucoma from other causes.

Shadow Test (Retinoscopy): When dilatation of the pupil without cycloplegic action is desired for the shadow test, the 2.5 percent ophthalmic solution may be used alone.

Blanching Test: One or 2 drops of the 2.5 percent ophthalmic solution should be applied to the injected eye. After five minutes, examine for perilimbal blanching. If blanching occurs, the congestion is superficial and probably does not indicate iritis.

How supplied

In Mono-Drop ® plastic dropper bottle: Low surface tension solutions

2.5 percent ophthalmic solution - Phenylephrine (phenylephrine hydrochloride ophthalmic solution) hydrochloride 2.5 percent in a sterile, isotonic, buffered, low surface tension vehicle with sodium phosphate, sodium biphosphate, boric acid, and, as antiseptic preservative, benzalkonium chloride, NF, 1:7500. The pH is adjusted with phosphoric acid or sodium hydroxide. Bottles of 15 mL (NDC 0024-1358-01).

10 percent ophthalmic solution- Phenylephrine (phenylephrine hydrochloride ophthalmic solution) hydrochloride 10 percent in a sterile, buffered, low surface tension vehicle with sodium phosphate, sodium biphosphate, and, as antiseptic preservative, benzalkonium chloride 1:10,000. The pH is adjusted with phosphoric acid or sodium hydroxide. Bottles of 5 mL (NDC 0024-1359-01).

Viscous solution

10 percent ophthalmic solution- Phenylephrine (phenylephrine hydrochloride ophthalmic solution) hydrochloride 10 percent in a sterile, buffered, viscous vehicle with sodium phosphate, sodium biphosphate, methylcellulose, and, as antiseptic preservative, benzalkonium chloride 1:10,000. The pH is adjusted with phosphoric acid or sodium hydroxide. Bottles of 5 mL (NDC 0024-1362-01).

Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86° F)

Manufactured for Sanofi-Synthelabo Inc. New York, NY 10016 by Abbott Laboratories North Chicago, IL 60064. Revised September 1999. FDA revision date: n/a

Phenylephrine interactions

See also:
What other drugs will affect Phenylephrine?

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: other decongestants (taken by mouth or sprayed into the nose), tricyclic antidepressants (such as nortriptyline, amitriptyline), MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine).

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

Phenylephrine may decrease the effectiveness of some blood pressure medications (such as beta blockers, reserpine, guanethidine, methyldopa, mecamylamine).

Phenylephrine and phenylephrine are available in both prescription and nonprescription products. Check the labels of all your medications to make sure you are not taking more than one product containing Phenylephrine or phenylephrine.

Phenylephrine can affect the results of certain lab tests (such as urine levels of certain acids). Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Phenylephrine side effects

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

Applies to phenylephrine: intravenous solution

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

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

Incidence not known:

  • Blurred vision
  • chest pain or discomfort
  • difficult or labored breathing
  • dizziness
  • fainting
  • fast, slow, or irregular heartbeat
  • headache
  • nausea or vomiting
  • nervousness
  • pain in the shoulders, arms, jaw, or neck
  • pounding in the ears
  • sweating
  • tightness in the chest
  • unusual tiredness

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

Symptoms of overdose:

  • Feeling of fullness in the head
  • pounding or rapid pulse
  • tingling in the arms or legs
  • vomiting

Minor Side Effects

Some of the side effects that can occur with phenylephrine 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:

Incidence not known:

  • Heartburn
  • itching skin
  • nausea
  • pain in the neck
  • pain or discomfort in chest, upper stomach, or throat

Phenylephrine contraindications

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

Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye.

If you wear contact lenses, remove them before applying phenylephrine ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication. Phenylephrine ophthalmic may contains preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

Do not use phenylephrine ophthalmic more often or continuously for longer than 48 to 72 hours without consulting a doctor. Chronic use of this medication may damage the blood vessels (veins and arteries) in the eyes. Consult a doctor if your symptoms do not improve or appear to worsen.

Use caution when driving, operating machinery, or performing other hazardous activities. Phenylephrine ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

Active ingredient matches for Ambroxol/Chlorpheniramine/Guaifenesin/Menthol/Phenylephrine:

Ambroxol/Chlorpheniramine/Guaifenesin/Menthol/Phenylephrine


List of Ambroxol/Chlorpheniramine/Guaifenesin/Menthol/Phenylephrine substitutes (brand and generic names)

Sort by popularity
Unit description / dosage (Manufacturer)Price, USD
BAROHIST P SYRUP 1 bottle / 100 ML syrup each (Baroda Pharma Pvt Ltd)$ 0.76
ESIRESP PLUS SYRUP 1 bottle / 100 ML syrup each (Mac Millon Pharmaceuticals Pvt Ltd)$ 0.79
Oritus-Plus Syrup (Orn Remedies Pvt Ltd)$ 1.08
SOTHREX PLUS SYRUP 1 bottle / 100 ML syrup each (Psychotropics India Ltd)$ 0.92

References

  1. DailyMed. "CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX: 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. "phenylephrine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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