DRUGS & SUPPLEMENTS

Hyflex

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What are the side effects you encounter while taking this medicine?

Hyflex uses


INDICATIONS AND USAGE

For the temporary relief of minor aches and pains associated with headaches, backache, muscular aches, the menstrual and premenstrual periods, colds, the flu, toothaches, as well as for minor pain from arthritis, and to reduce fever.

CONTRAINDICATIONS

This product should not be administered to patients who have previously exhibited hypersensitivity to Hyflex or phenyltoloxamine citrate.

Laboratory Tests

In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

Drug/Laboratory Test Interactions

Hyflex may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

The sedative effects of phenyltoloxamine citrate are additive to the CNS depressant effects of alcohol, hypnotics, sedatives and tranquilizers.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No adequate studies have been conducted in animals to determine whether phenyltoloxamine citrate or Hyflex have a potential for carcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Hyflex should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Hyflex is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known.

Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from phenyltoloxamine citrate and Hyflex, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

Dermatological

skin rash, pruritus.

The following adverse drug events may be borne in mind as potential effects of Hyflex: allergic reactions, rash, thrombocytopenia, agranulocytosis.

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OVERDOSAGE

Following an acute overdosage, toxicity may result from phenyltoloxamine citrate or Hyflex.

Hyflex

In Hyflex overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and thrombocytopenia may also occur.

Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams or fatalities with less than 15 grams.

Treatment

A single or multiple overdose with phenyltoloxamine citrate or Hyflex is a potentially lethal overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Vomiting should be induced mechanically, or with syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes).

If the dose of Hyflex may have exceeded 140 mg/kg, acetylcysteine should be administered as early as possible. Serum Hyflex levels should be obtained, since levels four or more hours following ingestion help predict Hyflex toxicity. Do not await Hyflex assay results before initiating treatment. Hepatic enzymes should be obtained initially, and repeated at 24-hour intervals. Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration. The toxic dose for adults for Hyflex is 10 g.

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DOSAGE

  • Adults (12 years and over) - ½ or 1 tablet every 4 - 6 hours.
  • Maximum daily dose - 5 tablets.
  • Children (6 to under 12 years) - ½ tablet every 4 - 6 hours.
  • Maximum daily dose - 2½ tablets
  • Do not give to children under the age of 6 years of age or exceed the recommended dosage unless directed by physician.

WARNINGS

Do not take this product for pain for more than 10 days (adults) or 5 days (children), and do not take for fever for more than 3 days unless directed by a physician. If pain or fever persists, if new symptoms occur, or if redness or swelling is present, consult a physician immediately because these could be signs of a serious condition. Do not give this product to children under 12 years of age for the pain of arthritis unless directed by a physician. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your physician. This preparation may cause drowsiness. Do not drive or operate machinery while taking this medication.

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

STORE AT ROOM TEMPERATURE 15° - 30°C (59° - 86°F). AVOID EXCESSIVE HEAT.

HOW SUPPLIED

Hyflex is available as a white tablet with "RELAGESIC" debossed on one and "IEL/650" debossed and scored on the other side, in bottles of 100 count NDC 11584-0476-1; sample packages and bottles of 500 tablets NDC 11584-0476-5.

Rx only

Distributed by:

International Ethical Labs, Inc.

San Juan, PR 00918-2627

Manufactured by:

Sage Pharmaceuticals, Inc.

Shreveport, LA 71109

Rev. 3/12

MG #11207

NDC 11584-0476-1

Hyflex

100 Tablets

Each tablet contains:

Acetaminophen 650mg

Phenyltoloxamine citrate 50mg

Rx Only

Distributed by:

INTERNATIONAL ETHICAL LABS

SAN JUAN, PR 00921

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Hyflex pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Hyflex available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Hyflex destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Hyflex Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Hyflex pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."FEVERALL INFANTS (ACETAMINOPHEN) SUPPOSITORY [ACTAVIS MID ATLANTIC LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."ACETAMINOPHEN; ASPIRIN; CAFFEINE: 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/dailym... (accessed August 28, 2018).
  3. "Phenyltoloxamine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Hyflex?

Depending on the reaction of the Hyflex after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Hyflex not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Hyflex addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Hyflex, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Hyflex consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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