Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension

Pronunciation: DEX-brome-fen-IR-a-meen/FEN-il-EF-rin/pir-IL-a-meen
Generic Name: Dexbrompheniramine/Phenylephrine/Pyrilamine
Brand Name: Poly Tan D

Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension is used for:

Relieving symptoms of sinus congestion, pressure, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension is an antihistamine and decongestant combination. The antihistamines work by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, which relieves congestion and pressure.

Do NOT use Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension if:

• you are allergic to any ingredient in Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension:

Some medical conditions may interact with Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a fast, slow, or irregular heartbeat


• if you have a history of asthma; lung problems (eg, emphysema); sleep apnea; adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; blood vessel problems; stroke; glaucoma or increased pressure in the eye; a blockage of your bladder, stomach, or intestines; ulcers; trouble sleeping; trouble urinating; an enlarged prostate or other prostate problems; seizures; kidney problems; thyroid problems; or phenylketonuria

Some MEDICINES MAY INTERACT with Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine ), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension's side effects


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension:

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

• Take Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension by mouth with or without food.


• Shake well before each use.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension, 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 Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension.

Important safety information:

• Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not take diet or appetite control medicines while you are taking Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension without checking with your doctor.


• Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension has dexbrompheniramine, pyrilamine, and phenylephrine in it. Before you start any new medicine, check the label to see if it has an antihistamine or a decongestant in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.


• Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension for a few days before the tests.


• Tell your doctor or dentist that you take Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension before you receive any medical or dental care, emergency care, or surgery.


• Use Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.


• Caution is advised when using Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension while you are pregnant. Do not take Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension in the third trimester of pregnancy. Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension is found in breast milk. Do not breast-feed while taking Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension.

Possible side effects of Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; 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:

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

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Dexbrompheniramine/Phenylephrine/Pyrilamine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular breathing; unusually fast, slow, or irregular heartbeat.

Proper storage of Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension:

Store Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension, please talk with your doctor, pharmacist, or other health care provider.


• Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Dexbrompheniramine/Phenylephrine/Pyrilamine Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Dexbrompheniramine/Phenylephrine/Pyrilamine resources

• Dexbrompheniramine/Phenylephrine/Pyrilamine Side Effects (in more detail)
• Dexbrompheniramine/Phenylephrine/Pyrilamine Use in Pregnancy & Breastfeeding
• Dexbrompheniramine/Phenylephrine/Pyrilamine Drug Interactions
• Dexbrompheniramine/Phenylephrine/Pyrilamine Support Group
• 0 Reviews for Dexbrompheniramine/Phenylephrine/Pyrilamine - Add your own review/rating

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• Nasal Congestion

Omeoformula 1 Adiposity

OMEOFORMULA®1-ADIPOSITY (Homeopathic complex preparation) INJECTION SC, ID, IM

1. INDICATIONS AND USAGE

1.1.    Treatment  of total body adiposity

1.2.    Treatment of localized adiposity

It is helpful to combine the treatment with oral detoxification therapy, in order to facilitate the elimination of the toxic load, activated by the injection therapy. Patients should also incorporate dietary modifications to facilitate weight loss.

2. DOSAGE AND ADMINISTRATION

2.1.    Treatment of total body adiposity for IM application: 1 vial 1-3 times a week according to severity and clinic evolution.

2.2.    Treatment of localized adiposity using mesotherapy technique: Apply 0,3 ml for each point. Using a 13 mm, 30G or a 4 mm, 27G needle, make the classic intradermal injections utilizing mesotherapy technique.

Application points: Apply to the affected area (abdomen, lower and upper limbs, gluteus muscles)or at acupuncture points.

Standard  protocol consists of one session a week for 5-7 weeks. For prolonged treatments, 2 sessions for the first week, 1 session a week for 1 month and then 1 session a month are recommended.

Discard unused solution.

2.3.    Opening of Vials: Use sterile needles and sterile syringe. Do not reuse. Do not use if foreign particles are present. Draw 1 cc of air into syringe, insert needle into vial inject air and withdraw the solution into the syringe.

3. DOSAGE FORMS AND STRENGTHS

3.1.    Injectable solution for subcutaneneous, intradermal, or intramuscular  administration. Pharmaceutical form: 2 ml glass vials.

3.2.    Each ingredient is attenuated according to the Homeopathic Pharmacopeia of United States.

Active ingredients: a-Ketoglutaricum acidum 6X; Adeps suillus 10X; Artery 6X; Barium oxalosuccinate 6X; Calcarea fluorica 10X; Calcarea fluorica 30X; Calcarea fluorica 200X; Carduus marianus 6X; Cis-Aconitic acid 6X; Citricum acidum 6X; DL malic acid 6X; Fucus vesiculosus 10X; Fucus vesiculosus 30X; Fucus vesiculosus 200X; Fumaricum acidum 6X; Hypophysis 10X; Hypophysis 30X; Hypophysis 200X; Magnesium gluconate 6X; Manganum phosphoricum 6X; Natrum oxalaceticum 6X; Natrum pyruvicum 6X;  Nicotinamidum 6X; Sarsaparilla 6X; Succinicum acidum 6X; Sulphur 12X; Thyroidinum 10X.

Inactive ingredient: Sterile isotonic sodium chloride solution.

4. CONTRAINDICATIONS

4.1.    There is no history of hypersensitivity to OMEOFORMULA®1-ADIPOSITY. However patients with a known hypersensitivity to any ingredient should be tested before use. Make a spot injection (0.1ml) into the forearm and observe for any reactions for 1 hour.

5. WARNINGS AND PRECAUTIONS

5.1.    Be sure to disinfect the area before application. Skin disinfection helps avoid infection at the site of administration that can result from saprophytic bacteria (i.e. atypical mycobacteria, staphylococcus genus) that may be present on the skin.

5.2.    Skin disinfection is required before application. Saprophytic bacteria may produce injection site abscesses with improper skin preparation.

6. ADVERSE REACTIONS

6.1.    The most common mild adverse reaction is slight reddening at the injection site due to the mechanical effect of the needle or a superficial skin reaction of mild erythema.

7. DRUG INTERACTIONS

7.1.    None Known.

8. USE IN SPECIFIC POPULATIONS

8.1    Pregnancy:  Pregnancy  category  C.  Animal  reproduction  studies  have  not  been conducted  with  OMEOFORMULA®1-ADIPOSITY.  OMEOFORMULA®1-ADIPOSITY should  not  be  administered  to  a pregnant woman. 

8.2    Nursing mothers:    It is not known whether any of the ingredients in OMEOFORMULA®1-ADIPOSITY  are  secreted  in  human milk.  However, since many drugs are secreted in human milk, caution should be exercised when OMEOFORMULA®1-ADIPOSITY is administered to a nursing woman.

8.3    Pediatric use: OMEOFORMULA®1-ADIPOSITY is  safe  to use  in adults 14 years and older.

8.4    Geriatric use: No restrictions.

9. DRUG ABUSE AND DEPENDENCE

9.1.    No Known.

10. OVERDOSAGE

10.1.    No Known.

11. DESCRIPTION

OMEOFORMULA®1- ADIPOSITY is a sterile solution made with isotonic sodium chloride solution.

OMEOFORMULA®1-ADIPOSITY formulation is based  on classical Homeopathy and  each ingredient has been selected according to the homeopathic description as referred to in Materia Medica

•    Fucus vesiculosus and Thyroidinum improve oxidative metabolic processes. Hypophysis and Adeps suillus enhance immune response against adiposities.  Sulfur, Carduus marianus, and Sarsaparilla permits the centrifugation of the connective tissue toxins,  the hepatic catabolism of fats, and activation of renal activity; 

•    Artery, and Calcarea fluorica act on tissue tonification  by stimulating increased vascularisation, combating exhaustion of the matrix. The Krebs cycle intermediates provide general stimulation of the cell emphasizing triglyceride hydrolysis (Fumaric acid), drainage (Malic acid) and support of connective tissue structure (alpa Keto- glutaric acid).

12. CLINICAL PHARMACOLOGY

12.1.    Mechanism of Action

The medication acts through a low-dose enzymatic mechanism.

12.2.    Pharmacodynamics

The physiological effects of OMEOFORMULA®1- ADIPOSITY is    are due to the effects of the ingredients according to their description in the Homeopathic Materia Medica.

12.3.    Pharmacokinetics

Homeopathic attenuation  provides complete bioavability of the active ingredients.

13. NONCLINICAL TOXICOLOGY

13.1.    OMEOFORMULA®1-ADIPOSITY has no level of toxicity due to the attenuation of the ingredients.

14. CLINICAL STUDIES

14.1.    OMEOFORMULA®1-ADIPOSITY formulation is based on classical Homeopathy and each ingredient has been selected according to the homeopathic description as refer in Materia Medica.

15. REFERENCES

15.1.    E.Italia, M. De Bellis: Manuale di Omeo-mesoterapia – Guna Ed. 1995.

15.2.    H.H.Reckeweg: Homeopathic Materia Medica omeopatica. Aurelia Verlag.

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1.    NDC  17089-272-31  10 glass vials packed in carton box

16.2.    NDC  17089-272-32  50 glass vials packed in carton box

16.3.    Store at room temperature, 20-25°C (68-77° F). Avoid  freezing  and  excessive  heat.

17. PATIENT COUNSELING INFORMATION

17.1.    Patients should be informed of the homeopathic approach and OMEOFORMULA®1-ADIPOSITY therapeutic goals.

PACKAGE LABEL

OMEOFORMULA1-ADIPOSITY  .alpha.-ketoglutaric acid - aconitic acid, cis - barium cation - calcium fluoride - citric acid monohydrate - fucus vesiculosus - fumaric acid - lard - magnesium gluconate - malic acid - manganese phosphate, dibasic - niacinamide - sarsaparilla - silybum marianum seed - sodium diethyl oxalacetate - sodium pyruvate - succinic acid - sulfur - sus scrofa artery - sus scrofa pituitary gland - thyroid -   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 17089-272 Route of Administration INTRADERMAL, SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LARD (LARD) LARD 10 [hp_X]  in 2 mL .ALPHA.-KETOGLUTARIC ACID (.ALPHA.-KETOGLUTARIC ACID) .ALPHA.-KETOGLUTARIC ACID 6 [hp_X]  in 2 mL SUS SCROFA ARTERY (SUS SCROFA ARTERY) SUS SCROFA ARTERY 6 [hp_X]  in 2 mL BARIUM OXALOSUCCINATE (BARIUM OXALOSUCCINATE) BARIUM OXALOSUCCINATE 6 [hp_X]  in 2 mL CALCIUM FLUORIDE (CALCIUM FLUORIDE) CALCIUM FLUORIDE 30 [hp_X]  in 2 mL SILYBUM MARIANUM SEED (SILYBUM MARIANUM SEED) SILYBUM MARIANUM SEED 6 [hp_X]  in 2 mL ACONITIC ACID, CIS- (ACONITIC ACID, CIS-) ACONITIC ACID, CIS- 6 [hp_X]  in 2 mL CITRIC ACID MONOHYDRATE (ANHYDROUS CITRIC ACID) CITRIC ACID MONOHYDRATE 6 [hp_X]  in 2 mL MALIC ACID (MALIC ACID) MALIC ACID 6 [hp_X]  in 2 mL FUCUS VESICULOSUS (FUCUS VESICULOSUS) FUCUS VESICULOSUS 30 [hp_X]  in 2 mL FUMARIC ACID (FUMARIC ACID) FUMARIC ACID 6 [hp_X]  in 2 mL SUS SCROFA PITUITARY GLAND (SUS SCROFA PITUITARY GLAND) SUS SCROFA PITUITARY GLAND 30 [hp_X]  in 2 mL MAGNESIUM GLUCONATE (MAGNESIUM CATION) MAGNESIUM GLUCONATE 6 [hp_X]  in 2 mL MANGANESE PHOSPHATE, DIBASIC (MANGANESE PHOSPHATE, DIBASIC) MANGANESE PHOSPHATE, DIBASIC 6 [hp_X]  in 2 mL SODIUM DIETHYL OXALACETATE (DIETHYL OXALACETATE) SODIUM DIETHYL OXALACETATE 6 [hp_X]  in 2 mL SODIUM PYRUVATE (PYRUVIC ACID) SODIUM PYRUVATE 6 [hp_X]  in 2 mL NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 6 [hp_X]  in 2 mL SARSAPARILLA (SARSAPARILLA) SARSAPARILLA 6 [hp_X]  in 2 mL SUCCINIC ACID (SUCCINIC ACID) SUCCINIC ACID 6 [hp_X]  in 2 mL SULFUR (SULFUR) SULFUR 12 [hp_X]  in 2 mL THYROID (THYROID) THYROID 10 [hp_X]  in 2 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.018 mL  in 2 mL WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 17089-272-31 10 VIAL In 1 BOX contains a VIAL, GLASS 1 2 mL In 1 VIAL, GLASS This package is contained within the BOX (17089-272-31) 2 17089-272-32 50 VIAL In 1 BOX contains a VIAL, GLASS 2 2 mL In 1 VIAL, GLASS This package is contained within the BOX (17089-272-32)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/29/2006

Labeler - Guna spa (430538264)

Establishment
Name	Address	ID/FEI	Operations
Guna spa		430538264	manufacture

Revised: 06/2010Guna spa

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