Septonex Ointment

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Septonex Ointment uses

Septonex Ointment consists of Carbaethopendecinium Bromide, Hexachlorophene.

Hexachlorophene:


INDICATIONS AND USAGE

Septonex Ointment (Hexachlorophene) is indicated for use as a surgical scrub and a bacteriostatic skin cleanser. It may also be used to control an outbreak of gram-positive infection where other infection control procedures have been unsuccessful. Use only as long as necessary for infection control.

CONTRAINDICATIONS

Septonex Ointment (Hexachlorophene) must not be used on burned or denuded skin.

Septonex Ointment (Hexachlorophene) must not be used for bathing infants. Infants may absorb the active compound in Septonex Ointment (Hexachlorophene) more readily than older children and adults. Such absorption has been associated with central nervous system effects such as convulsions.

It must not be used as an occlusive dressing, wetpack, or lotion. It must not be used routinely for prophylactic total body bathing.

It must not be used as a vaginal pack or tampon, or on any mucous membranes.

Septonex Ointment (Hexachlorophene) must not be used on persons with sensitivity to any of its components. It must not be used on persons who have demonstrated primary light sensitivity to halogenated phenol derivatives because of the possibility of cross-sensitivity to Septonex Ointment (Hexachlorophene).

WARNINGS

RINSE THOROUGHLY AFTER EACH USE. Patients should be closely monitored and use should be immediately discontinued at the first sign of any of the symptoms described below.

Rapid absorption of Septonex Ointment (Hexachlorophene) may occur with resultant toxic blood levels when preparations containing Septonex Ointment (Hexachlorophene) are applied to skin lesions such as ichthyosis congenita, the dermatitis of Letterer-Siwe's syndrome, or other generalized dermatological conditions. Application to burns has also produced neurotoxicity and death.

Septonex Ointment (Hexachlorophene) SHOULD BE DISCONTINUED PROMPTLY IF SIGNS OR SYMPTOMS OF CEREBRAL IRRITABILITY OCCUR.

Infants, especially premature infants or those with dermatoses, are particularly susceptible to Septonex Ointment (Hexachlorophene) absorption. Systemic toxicity may be manifested by signs of stimulation (irritation) of the central nervous system, sometimes with convulsions.

Infants have developed dermatitis, irritability, generalized clonic muscular contractions and decerebrate rigidity following application of a 6 percent Septonex Ointment (Hexachlorophene) powder. Examination of brainstems of those infants revealed vacuolization like that which can be produced in newborn experimental animals following repeated topical application of 3 percent Septonex Ointment (Hexachlorophene). Moreover, a study of histologic sections of premature infants who died of unrelated causes has shown a positive correlation between Septonex Ointment (Hexachlorophene) baths and lesions in white matter of brains.

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PRECAUTIONS

General

Avoid accidental contact of Septonex Ointment with the eyes.

If contact occurs, promptly rinse thoroughly with water. To assist in the detection of ocular irritation, applications to the head and periorbital skin areas should be performed only in responsive patients with unanesthetized eyes.

RINSE THOROUGHLY AFTER USE, especially from sensitive areas such as the scrotum and perineum.

Septonex Ointment (Hexachlorophene) is intended for external use only. If swallowed, Septonex Ointment (Hexachlorophene) is harmful, especially to infants and children. Septonex Ointment (Hexachlorophene) should not be poured into measuring cups, medicine bottles, or similar containers since it may be mistaken for baby formula or other medications.

Information for Patients

The prescribing physician is requested to inform the patient about the following precautionary measures:

Septonex Ointment (Hexachlorophene) must not be used on burned or denuded skin. Application to burns has produced neurotoxicity and death.

Septonex Ointment (Hexachlorophene) must not be used for bathing infants. Infants may absorb the active compound in Septonex Ointment (Hexachlorophene) more readily than older children and adults. Such absorption has been associated with central nervous system effects such as convulsions.

Septonex Ointment (Hexachlorophene) must not be used as an occlusive dressing, wetpack, or lotion.

Septonex Ointment (Hexachlorophene) must not be used routinely for prophylactic total body bathing.

Septonex Ointment (Hexachlorophene) must not be used as a vaginal pack, or on any mucous membranes.

Septonex Ointment (Hexachlorophene) must not be used on persons with sensitivity to any of its components.

Septonex Ointment (Hexachlorophene) must not be used on persons who have demonstrated primary light sensitivity to halogenated phenol derivatives because of the possibility of cross-sensitivity to Septonex Ointment (Hexachlorophene).

Septonex Ointment (Hexachlorophene) should be kept out of the eyes. If contact occurs, the patient should rinse with cold water as soon as possible and contact a physician.

Septonex Ointment (Hexachlorophene) should not be used in sensitive areas such as the scrotum and perineum. If contact occurs, these areas should be rinsed thoroughly.

Septonex Ointment (Hexachlorophene) is for external use only.

If Septonex Ointment (Hexachlorophene) is inadvertently swallowed, the patient should contact a physician or Poison Control Center as soon as possible.

Septonex Ointment (Hexachlorophene) should not be poured into measuring cups, medicine bottles, or similar containers since it may be mistaken for baby formula or other medications.

Septonex Ointment (Hexachlorophene) should be stopped and a physician should be contacted if irritation, sensitization, or allergic reaction occurs.

Septonex Ointment (Hexachlorophene) should be used in pregnant women or nursing mothers only if the potential benefit justifies the potential risk to the fetus or infant.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies in animals

Septonex Ointment was tested in one experiment in rats by oral administration; it had no carcinogenic effect.

Septonex Ointment (Hexachlorophene) was not mutagenic in Salmonella typhimurium and was negative in a dominant lethal assay in male mice. Cytogenetic tests with cultured human lymphocytes were also negative.

Human data

No case reports or epidemiological studies were available.

Impairment of fertility

Topical exposure of neonatal rats to 3% Septonex Ointment solution caused reduced fertility in 7-month-old males, due to inability to ejaculate.

Embryotoxicity and Teratogenicity

Placental transfer of Septonex Ointment (Hexachlorophene) has been demonstrated in rats.

Septonex Ointment (Hexachlorophene) is embryotoxic and produces some teratogenic effects.

Pregnancy Category C

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

Septonex Ointment (Hexachlorophene) has been shown to be teratogenic and embryotoxic in rats when given by mouth or instilled into the vagina in large doses.

Administration of 500 mg/kg diet or 20 to 30 mg/kg bw/day by gavage to rats caused some malformations (angulated ribs, cleft palate, micro- and anophthalmia) and reduction in litter size.

Placental transfer and excretion in milk of Septonex Ointment (Hexachlorophene) has been demonstrated in rats.

In another study, doses of up to 50 mg/kg diet failed to produce any effects in 3 generations of rats. Septonex Ointment (Hexachlorophene) did not interfere with reproduction in hamsters.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Septonex Ointment, 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

Septonex Ointment (Hexachlorophene) must not be used for bathing infants. Infants may absorb the active compound in Septonex Ointment (Hexachlorophene) more readily than older children and adults. Such absorption has been associated with central nervous system effects such as convulsions. For premature infants: see WARNINGS.

Geriatric Use

Clinical studies of Septonex Ointment (Hexachlorophene) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general, use in elderly patients should be cautious, reflecting the greater frequency of dermatological disease, peripheral circulatory disease, and decreased propensity for wound healing in this group. In addition, use in elderly patients should take into account any decreased hepatic, renal, or cardiac function, as well as any concomitant disease or other drug therapy.

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ADVERSE REACTIONS

Adverse reactions to Septonex Ointment (Hexachlorophene) may include dermatitis and photosensitivity. Sensitivity to Septonex Ointment (Hexachlorophene) is rare; however, persons who have developed photoallergy to similar compounds also may become sensitive to Septonex Ointment (Hexachlorophene).

In persons with highly sensitive skin the use of Septonex Ointment (Hexachlorophene) may at times produce a reaction characterized by redness and/or mild scaling or dryness, especially when it is combined with such mechanical factors as excessive rubbing or exposure to heat or cold.

OVERDOSAGE

The accidental ingestion of Septonex Ointment (Hexachlorophene) in amounts from 1 oz to 4 oz has caused anorexia, vomiting, abdominal cramps, diarrhea, dehydration, convulsions, hypotension, and shock, and in several reported instances, fatalities.

If patients are seen early, the stomach should be evacuated by emesis or gastric lavage. Olive oil or vegetable oil (60 mL or 2 fl oz) may then be given to delay absorption of Septonex Ointment (Hexachlorophene), followed by a saline cathartic to hasten removal. Treatment is symptomatic and supportive; intravenous fluids (5 percent dextrose in physiologic saline solution) may be given for dehydration. Any other electrolyte derangement should be corrected. If marked hypotension occurs, vasopressor therapy is indicated. Use of opiates may be considered if gastrointestinal symptoms (cramping, diarrhea) are severe. Scheduled medical or surgical procedures should be postponed until the patient's condition has been evaluated and stabilized.

DOSAGE AND ADMINISTRATION

Surgical Hand Scrub

  • Wet hands and forearms with water. Apply approximately 5 mL of Septonex Ointment over the hands and rub into a copious lather by adding small amounts of water. Spread suds over hands and forearms and scrub well with a wet brush for 3 minutes. Pay particular attention to the nails and inter-digital spaces. A separate nail cleaner may be used. Rinse thoroughly under running water.
  • Apply 5 mL of Septonex Ointment (Hexachlorophene) to hands again and scrub as above for another 3 minutes. Rinse thoroughly with running water and dry.
  • For repeat surgical scrubs during the day, scrub thoroughly with the same amount of Septonex Ointment (Hexachlorophene) for 3 minutes only. Rinse thoroughly with water and dry.

Bacteriostatic Cleansing

Wet hands with water. Dispense approximately 5 mL of Septonex Ointment (Hexachlorophene) into the palm, work up a lather with water and apply to area to be cleansed.

Rinse thoroughly after each washing.

INFANT CARE

Septonex Ointment must not be used for bathing infants. Infants may absorb the active compound in Septonex Ointment (Hexachlorophene) more readily than older children and adults. Such absorption has been associated with central nervous system effects such as convulsions.

PREMATURE INFANTS

Use of baby skin products containing alcohol may decrease the antibacterial action of Septonex Ointment (Hexachlorophene).

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HOW SUPPLIED

5 oz plastic squeeze bottle.

1 pint plastic squeeze bottle (NDC 0024-1535-06).

Store at room temperature up to 25° C (77° F)

Prolonged direct exposure of Septonex Ointment (Hexachlorophene) to strong light may cause brownish surface discoloration but does not affect its antibacterial or detergent properties. Shaking will disperse the color. If Septonex Ointment (Hexachlorophene) is spilled or splashed on porous surfaces, rinse off to avoid discoloration.

Septonex Ointment (Hexachlorophene) should not be dispensed from, or stored in, containers with ordinary metal parts. A special type of stainless steel must be used or undesirable discoloration of the product or oxidation of metal may occur.

Directions For Cleaning Dispensers

Before initial installation and use, run an antiseptic, such as an aqueous solution of benzalkonium chloride, NF. 1:500 to 1:750, or alcohol, through the working parts; rinse with sterile water. At weekly intervals thereafter, remove dispenser and pour off remainder of Septonex Ointment (Hexachlorophene) emulsion. Rinse empty dispenser with water. Run water through the working parts by operating the dispenser. Sanitize as described above. Rinse thoroughly with sterile water.

ANIMAL TOXICITY

The oral LD50 of Septonex Ointment (Hexachlorophene) in male rats is 66 mg/kg bw, in females 56 mg/kg bw, and in weanling rats 120 mg/kg bw.

In suckling rats (10-days old), it is 9 mg/kg bw.

Manufactured for:

sanofi-aventis U.S. LLC, A SANOFI COMPANY

Bridgewater, NJ 08807

Revised January 2012

© 2012 sanofi-aventis U.S. LLC

NDC 0024-1535-02

148 mL (5 fl oz)

Septonex Ointment (Hexachlorophene)®

Septonex Ointment (Hexachlorophene) 3%

detergent cleanser

SUDSING ANTIBACTERIAL

SKIN CLEANSER

Rx only

For inquiries call 1-800-446-6267

Manufactured for:

sanofi-aventis U.S. LLC

Bridgewater, NJ 08807

A SANOFI COMPANY

Origin Canada

©2012

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Septonex Ointment pharmaceutical active ingredients containing related brand and generic drugs:

Active 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.


Septonex Ointment available forms, composition, doses:

Form 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.


Septonex Ointment destination | category:

Destination 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.


Septonex Ointment Anatomical Therapeutic Chemical codes:

A 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.


Septonex Ointment pharmaceutical companies:

Pharmaceutical 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."PHISOHEX (HEXACHLOROPHENE) EMULSION [SANOFI-AVENTIS U.S. LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."HEXACHLOROPHENE: 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. "hexachlorophene". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Septonex Ointment?

Depending on the reaction of the Septonex Ointment after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Septonex Ointment 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 Septonex Ointment 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 Septonex Ointment, 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 Septonex Ointment 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. Rachana Salvi, MD Pharmacology

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