Xeglyze

 

Class: Scabicides and Pediculicides

Chemical Name: 5-methyl-2-(5-methylpyridin-2-yl)pyridine
Molecular Formula: C ₁₂H ₁₂N ₂
CAS Number: 1134-35-6
Brands: Xeglyze

What is Xeglyze

Xeglyze is an invasive drug that kills pediculosis.

 

Uses for Xeglyze

Xeglyze is used for the following purposes:

Xeglyze lotion can be used to treat lice infestations in head lice among patients who are 6 months old or older. Abametapir is recommended to be utilized within the context of a comprehensive lice management program.

Get rid of (with boiling bathing water) or dry-clean recently worn clothing, hats used bedding, towels and clothing.

Take care to wash personal care items like combs, hair clips, and brushes in hot water.¶

Use a fine-tooth or a special nit comb to get rid of dead lice or nits.

Xeglyze Dosage and Administration

General

Xeglyze comes in the dosing form(s) as well as strength(s):

Lotion: 0.74% (w/w).

Dosage

It is imperative to ensure that the labelling provided by the manufacturer is read for more details regarding the dosage and administration of this medication. Summary of dosage:

Pediatric Patients

Dosage and Administration

• Use only for topical purposes. It is not intended for oral or intravaginal use.
• Shake well prior to use.
• Apply the lotion to dry hair in a quantity enough (up to the entire contents from the bottle) to cover the scalp and hair. Avoid contact with the eyes.
• Massage Xeglyze lotion onto the scalp and all over the hair. Leave on the scalp and hair for 10 minutes, then wash off with warm water.
• Wash hands after application. Hair shampooing can be done at any time following the treatment.
• The treatment with Xeglyze lotion is one application. Get rid of any product that isn’t used. Do not flush contents into the sink or on the toilet.

Adults

Dosage and Administration

• Only for topical use. Not intended for oral or intravaginal use.
• Shake well before using.
• Apply the lotion to dry hair in amounts enough (up to the total amount in the bottle) to completely coat the scalp and hair. Avoid contact with the eyes.
• Massage Xeglyze cream into the scalp and all over the hair. Leave it on the scalp and hair for 10 minutes, then wash it off using warm water.
• Wash hands after application. Hair shampooing can be done at any time following the treatment.
• Treatment with Xeglyze lotion requires only one application. Get rid of any remaining product. Don’t flush it down in the sink or on the toilet.

Cautions for Xeglyze

Contraindications

None.

Warnings/Precautions

Risk of Neonatal Benzyl Alcohol Toxicity

Abametapir lotion is made up of Benzyl Alcohol. The exposure of the body to benzyl Alcohol has been linked to serious or fatal reactions, including “gasping syndrome” in neonates as well as infants born with low birth weight. “Gasping Syndrome” is a term used to describe the “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis and gasping respiratory. The amount of benzyl-alcohol in which toxicities can occur isn’t established. Infants born prematurely and with low birth weight could be more likely to develop toxic effects.

The effectiveness and safety of Xeglyze lotion have not been proven in children who are younger than the age of 6 months. It is not recommended for pediatric patients younger than six months old because of the possibility of increased systemic absorption.

Potential risk Benzyl Alcohol Toxicity from Accidental Ingestion

To prevent accidental ingestion by children Xeglyze lotion must only be administered under the direct supervision of an adult.

Consumption of benzyl alcohol in large amounts can cause gastrointestinal (nausea vomiting, diarrhea, and nausea) as well as the central nervous system (headache convulsions, ataxia and coma) undesirable reactions. Acute adverse reactions can include respiratory depression, death and even death. If you accidentally swallow something, inform the patient or caregiver to contact the Poison Control Center at 1-800-222-1222.

Specific Populations

Pregnancy

Risk summary: There are no known data about Xeglyze usage during pregnancy to determine the risk associated with this drug of birth defects that are major miscarriage, adverse pregnancy or foetal outcomes.

The study of embryofetal development was that were conducted using the oral administration of Xeglyze throughout organogenesis, there was no evidence for any malformations or harm to the fetus in addition to maternal toxicity, which was observed in pregnant rats or rabbits, at doses that generated exposures as high as 50 times, or equivalent to an MRHD of the maximal recommended for human consumption (MRHD) in both rats and rabbits,

The dose that was the highest in rabbits was restricted due to the maternal toxicity caused by the vehicle that was used during the experiment.

The risk of background birth defects or miscarriage in the specific population is not known. Within general, in the U.S. general population, the approximate risk of major miscarriages and birth defects in pregnant women who are clinically confirmed is between 2 to 15% or 15-20% respectively.

animal data: Systemic embryofetal development studies were conducted on rabbits and rats. Oral doses of 10,25 and 75 mg/kg/day Xeglyze was administered during the time of organogenesis (gestational 7 to 17 days) to rats that were pregnant. If there was embryo-fetal toxicity and maternal toxicities (lower body weights of the fetus as well as delayed Ossification) was observed in the range of 75 mg/kg/day. There were no treatment-related effects on malformations were observed with 75 mg/kg/day (50 more than the MRHD in the context of C _Max comparators).

Oral doses of 4,16 and 40 mg/kg/day of Xeglyze were given during the organogenesis period (gestational between days 6-19) to rabbits that were pregnant. There were no effects of treatment on embryofetal malformations or toxicity were observed with doses of 40 mg/kg/day (approximately 1x the MRHD from C _maximum and C max comparisons). Maternal toxicity due to the drug limited the dosage that could be used in rabbits that are pregnant.

In a postnatal and perinatal research study of the development of rats oral doses of 10 25 mg/kg/day, 75 mg/kg/day and 10 mg/kg/ were administered starting at the start of the process of organogenesis (gestational day 6) to the close in lactation (lactation day 20).

In the event of maternal toxicities, embryo-fetal lethality and a decrease in body weight gain of the fetus were observed in the 75 mg/kg/day range. There were no effects from treatment regarding postnatal development was observed in the 75 mg/kg/day range (47 per cent of MRHD from C _maximum comparators).

Lactation

There is no information available about Xeglyze presence in human milk, or the effect of Xeglyze on the infant who is breastfed or on the production of milk. The health and developmental benefits of breastfeeding must be taken into consideration along with the mother’s medical requirement for Xeglyze, as well as any possible adverse effects that could affect the infant who is breastfed by Xeglyze or the condition that is underlying to the mother.

Pediatric Use

The efficacy and safety of Xeglyze lotion are confirmed in children six months and older.

The efficacy and safety of Xeglyze lotion have not been proven in children who are less than 6 months of age. Xeglyze lotion has not been advised for patients younger than 6 months of age due to the possibility for higher absorption into the system due to the high ratio of body surface mass, and the possibility of an undeveloped skin barrier.

Abametapir lotion is a source of benzyl alcohol. It has been linked with severe adverse reactions and death in neonates as well as babies with low birth weight. It is believed that the “gasping syndrome” (characterized by central nervous system depression, metabolic acidosis gasping respirations, as well as the high concentrations of benzyl alcohol and its metabolites in urine and blood) is associated with doses of benzyl Alcohol administered intravenously more than 99 mg/kg/day in newborns as well as infants born with low birth weights.

Other symptoms could include neurological decline, seizures hemorrhage in the intracranial area, hematologic disorders skin breakdown, hepatic and kidney failure, hypotension, bradycardia, as well as cardiovascular collapse.

The minimal amount of benzyl-alcohol that can cause toxicity isn’t determined. Infants born prematurely or with low birth weight and patients who are taking high doses could be more prone to developing toxic effects.

Due to the possibility of accidental consumption, the lotion must be administered to children only under the supervision of an adult. (See Risk of Benzyl Alcohol Toxicity from Accidental Ingestion under Cautions: Warnings/Precautions.)

Geriatric Use

The clinical studies on Xeglyze lotion didn’t include enough samples of people over 65 years old to determine if they react differently than younger people. Other clinical studies have not found any significant differences in the responses between younger and older subjects.

Common Adverse Effects

The most common negative reactions (incidence of 1%) were rash, erythema as well as skin burning sensations. vomiting, contact dermatitis eye irritation, pruritus and changes in hair colour.

Drug Interactions

Specific Drugs

It is crucial to ensure that the labelling provided by the manufacturer is reviewed for more specific information about interactions with this medication as well as potential dose adjustments. Highlights of interactions:

For the first two weeks following the application of Xeglyze lotion stay clear of taking any drugs that act as substrates for CYP3A4, CYP2B6 or CYP1A2. If you are not using them, avoid the use of abametapir lotion.

Drug Actions

Mechanism of Action

Xeglyze is an inhibitor of metalloproteinase. Metalloproteinases are involved in the physiological processes essential for egg development and the life span of lice.

Advice to Patients

Patient Counseling Information

The patient or caregiver should be advised to review the FDA-approved patient warning label (Patient information and instructions for use).

The patient and the caregiver should be informed of the following directions:

Avoid abametapir cream.

Keep out of the reach of children. Keep out of reach. Children should use the product under the control of an adult due to the danger of benzyl alcohol toxic effects.

Avoid contact with your eyes.

Wash hands after application.

Hair can be washed anytime following the treatment.

The treatment with Xeglyze lotion is only one application. Don’t stop.

Recycle any portion that is not used. Don’t flush the contents into the sink or on the toilet.

Additional Information

For further details until a more thorough monograph is prepared and published the labelling provided by the manufacturer must be read. It is vital that the labelling of the manufacturer be reviewed for more specific details on the usual dosage, uses, and administration, precautions and precautions, contraindications, possible interactions with drugs as well as laboratory test interferences and acute toxic effects.

Preparations

Excipients that are found in commercially available drugs may cause beneficial clinical effects on certain people; refer to the specific product labelling for further information.

 

Abametapir

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Topical	Lotion	0.74% (w/w)	Xeglyze	Dr. Reddy’s Laboratories Inc.