PHARMA NEWS

FDA approves expanded indication for Qudexy XR (Topiramate) for pediatric patients

Upsher-Smith Laboratories, Inc. (Upsher-Smith) announced that it has received U.S. Food and Drug Administration (FDA) approval of a supplemental new drug application (sNDA) for Qudexy XR (topiramate) extended-release capsules for use as initial monotherapy in patients two years of age and older who are experiencing partial-onset seizures (POS) or primary generalized tonic-clonic seizures.
Qudexy XR capsules are the only once-daily extended-release topiramate product to have received this expanded indication and to be approved for administration by sprinkling their contents onto soft food, making them a useful option for young children who may have difficulty swallowing whole capsules or tablets.
Qudexy XR is a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.
“The expanded indication gives physicians the option to
prescribe Qudexy XR as initial monotherapy in patients as young as two years old,” said William Pullman, MB BS, BMedSc, PhD, FRACP, Chief Scientific Officer, Upsher-Smith.
“This, combined with its ability to be sprinkled on soft food for ease of administration, makes it a viable treatment option for the pediatric patient population.”
Qudexy XR was previously approved for use as initial monotherapy in patients 10 years of age and older with POS or primary generalized tonic-clonic seizures.
Qudexy XR is also approved as an adjunctive therapy in patients two years of age or older with POS, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome..n
Source: drugs.com
 
Sunscreen topical
Uses
Sunscreens are used to protect the skin from the harmful effects of the sun. They help to prevent sunburn and premature aging (e.g., wrinkles, leathery skin). Sunscreens also help to decrease the risk of skin cancer and also of sunburn-like skin reactions
(sun sensitivity) caused by some medications (e.g., tetracyclines, sulfa drugs, phenothiazines such as chlorpromazine).
The active ingredients in sunscreens work either by absorbing the sun's ultraviolet (UV) radiation, preventing it from reaching the deeper layers of the skin, or by reflecting the radiation.
Wearing sunscreen does
not mean that you can stay out longer in the sun. Sunscreens cannot protect against all of the sun's radiation.
There are various types of sunscreens available in many forms (e.g., cream, lotion, gel, stick, spray, lip balm).
How to use sunscreen topical
Sunscreens are for use on the skin only. Follow all directions on the product package.
If you are uncertain about any of the information, consult your doctor or pharmacist.
Apply sunscreen generously to all exposed skin 30 minutes before sun exposure. As a general guide, use 1 ounce (30 grams) to cover your entire body. Reapply the sunscreen after swimming or sweating or drying off with a towel or if it has rubbed off.
If you are outside for long periods, reapply sunscreen every 2 hours. If you are using the lip balm form, apply to the lip area only.
The spray form is flammable. If using the spray, avoid smoking when applying this medication and do not use or store it near heat or open flame.
When applying sunscreen to the face, be careful to avoid contact with the eyes. If the sunscreen gets in your eyes, rinse thoroughly with water.
Use cautiously or avoid use on irritated skin.
Do not use sunscreen on infants younger than 6 months unless the doctor directs you to do so. It is best for infants to stay out of the sun and wear protective clothing (e.g., hats, long sleeves/pants) when outdoors.
If you develop a serious sunburn, or if you think you may have a serious medical problem, seek immediate medical attention.
Side effects
Some sunscreen products (e.g., those containing aminobenzoic acid or para-aminobenzoic acid/PABA) may stain clothing.
Some ingredients of sunscreens can cause the skin to become more sensitive. If a sunscreen causes redness or irritation, wash it off and stop using it. Talk to your doctor or pharmacist about using another sunscreen product with different ingredients.
If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
Precautions
Before using a sunscreen, tell your doctor or pharmacist if you are allergic to any of its ingredients (e.g., aminobenzoic acid/PABA); or to some types of anesthetic drugs (e.g., benzocaine, tetracaine); or to sulfa drugs; or if you have any other allergies.
This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Interactions
If you are using this product under your doctor's direction, your doctor or pharmacist may already be aware of possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.
Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
Finding the best sunscreen
Sunscreens help shield you from the sun's dangerous ultraviolet (UV) rays in two ways. Some work by scattering the light, reflecting it away from your body. Others absorb the UV rays before they reach your skin.
A few years ago, choosing a good sunscreen meant you just looked for a high sun protection factor (SPF) -- which rates how well the sunscreen protects against one type of cancer-causing UV ray, ultraviolet B (UVB). SPF refers to blockage of UVB rays only.
Research soon showed that ultraviolet A rays (UVA) also increase skin cancer risk. While UVA rays don't cause sunburn, they penetrate deeply into skin and cause wrinkles.
The Environmental Protection Agency estimates that up to 90% of skin changes associated with aging are really caused by a lifetime's exposure to UVA rays.

 

 

 

 

PHARMA NEWS

FDA approves expanded indication for Qudexy XR (Topiramate) for pediatric patients Upsher-Smith Laboratories, Inc. (Upsher-Smith) announced that it has received U.S. Food and Drug Administration (FDA) approval of a supplemental new drug application (sNDA) for Qudexy XR (topiramate) extended-release capsules for use as initial monotherapy in patients two years of age and older who are experiencing partial-onset seizures (POS) or primary generalized tonic-clonic seizures. Qudexy XR capsules are the only once-daily extended-release topiramate product to have received this expanded indication and to be approved for administration by sprinkling their contents onto soft food, making them a useful option for young children who may have difficulty swallowing whole capsules or tablets. Qudexy XR is a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile. The expanded indication gives physicians the option to prescribe Qudexy XR as initial monotherapy in patients as young as two years old, said William Pullman, MB BS, BMedSc, PhD, FRACP, Chief Scientific Officer, Upsher-Smith. This, combined with its ability to be sprinkled on soft food for ease of administration, makes it a viable treatment option for the pediatric patient population. Qudexy XR was previously approved for use as initial monotherapy in patients 10 years of age and older with POS or primary generalized tonic-clonic seizures. Qudexy XR is also approved as an adjunctive therapy in patients two years of age or older with POS, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome..n Source: drugs.com Sunscreen topical Uses Sunscreens are used to protect the skin from the harmful effects of the sun. They help to prevent sunburn and premature aging (e.g., wrinkles, leathery skin). Sunscreens also help to decrease the risk of skin cancer and also of sunburn-like skin reactions (sun sensitivity) caused by some medications (e.g., tetracyclines, sulfa drugs, phenothiazines such as chlorpromazine). The active ingredients in sunscreens work either by absorbing the suns ultraviolet (UV) radiation, preventing it from reaching the deeper layers of the skin, or by reflecting the radiation. Wearing sunscreen does not mean that you can stay out longer in the sun. Sunscreens cannot protect against all of the suns radiation. There are various types of sunscreens available in many forms (e.g., cream, lotion, gel, stick, spray, lip balm). How to use sunscreen topical Sunscreens are for use on the skin only. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist. Apply sunscreen generously to all exposed skin 30 minutes before sun exposure. As a general guide, use 1 ounce (30 grams) to cover your entire body. Reapply the sunscreen after swimming or sweating or drying off with a towel or if it has rubbed off. If you are outside for long periods, reapply sunscreen every 2 hours. If you are using the lip balm form, apply to the lip area only. The spray form is flammable. If using the spray, avoid smoking when applying this medication and do not use or store it near heat or open flame. When applying sunscreen to the face, be careful to avoid contact with the eyes. If the sunscreen gets in your eyes, rinse thoroughly with water. Use cautiously or avoid use on irritated skin. Do not use sunscreen on infants younger than 6 months unless the doctor directs you to do so. It is best for infants to stay out of the sun and wear protective clothing (e.g., hats, long sleeves/pants) when outdoors. If you develop a serious sunburn, or if you think you may have a serious medical problem, seek immediate medical attention. Side effects Some sunscreen products (e.g., those containing aminobenzoic acid or para-aminobenzoic acid/PABA) may stain clothing. Some ingredients of sunscreens can cause the skin to become more sensitive. If a sunscreen causes redness or irritation, wash it off and stop using it. Talk to your doctor or pharmacist about using another sunscreen product with different ingredients. If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Precautions Before using a sunscreen, tell your doctor or pharmacist if you are allergic to any of its ingredients (e.g., aminobenzoic acid/PABA); or to some types of anesthetic drugs (e.g., benzocaine, tetracaine); or to sulfa drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Interactions If you are using this product under your doctors direction, your doctor or pharmacist may already be aware of possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Finding the best sunscreen Sunscreens help shield you from the suns dangerous ultraviolet (UV) rays in two ways. Some work by scattering the light, reflecting it away from your body. Others absorb the UV rays before they reach your skin. A few years ago, choosing a good sunscreen meant you just looked for a high sun protection factor (SPF) -- which rates how well the sunscreen protects against one type of cancer-causing UV ray, ultraviolet B (UVB). SPF refers to blockage of UVB rays only. Research soon showed that ultraviolet A rays (UVA) also increase skin cancer risk. While UVA rays dont cause sunburn, they penetrate deeply into skin and cause wrinkles. The Environmental Protection Agency estimates that up to 90% of skin changes associated with aging are really caused by a lifetimes exposure to UVA rays.