Propoxacet-N 100

Generic Name: propoxyphene and acetaminophen (Oral route)

a-seet-a-MIN-oh-fen, proe-POX-i-feen NAP-si-late

Oral route(Tablet)

Accidental and intentional overdose with propoxyphene products either alone or in combination with other CNS depressants, including alcohol, has occurred, and may be fatal within the first hour. Many of the fatalities have occurred in patients with previous histories of emotional disturbances or suicidal ideation/attempts and/or concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs. Do not prescribe propoxyphene for patients who are suicidal or have a history of suicidal ideation. The metabolism of propoxyphene may be altered by strong CYP3A4 inhibitors leading to enhanced propoxyphene plasma levels; monitor patients closely and adjust dosages if necessary in patients receiving any CYP3A4 inhibitor concomitantly .

Commonly used brand name(s)

In the U.S.

• Balacet 325


• Darvocet A500


• Darvocet-N 100


• Darvocet-N 50


• Pronap-100


• Propoxacet-N


• Propoxacet-N 100

Available Dosage Forms:

• Tablet

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Propoxyphene

Uses For Propoxacet-N 100

Propoxyphene and acetaminophen combination is used to relieve mild to moderate pain. Propoxyphene belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.

When propoxyphene is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

Products containing propoxyphene were withdrawn from the U.S. market starting November 19, 2010.

This medicine was available only with your doctor's prescription.

Before Using Propoxacet-N 100

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of propoxyphene and acetaminophen combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of propoxyphene and acetaminophen combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving propoxyphene and acetaminophen combination.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Naltrexone


• Rasagiline


• Selegiline

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adinazolam


• Alfentanil


• Alprazolam


• Amobarbital


• Anileridine


• Aprobarbital


• Bromazepam


• Brotizolam


• Buprenorphine


• Butabarbital


• Butalbital


• Butorphanol


• Carbamazepine


• Carisoprodol


• Chloral Hydrate


• Chlordiazepoxide


• Chlorzoxazone


• Clobazam


• Clonazepam


• Clorazepate


• Codeine


• Dantrolene


• Dezocine


• Diazepam


• Estazolam


• Ethchlorvynol


• Fentanyl


• Flunitrazepam


• Flurazepam


• Fospropofol


• Halazepam


• Hydrocodone


• Hydromorphone


• Ketazolam


• Levorphanol


• Lorazepam


• Lormetazepam


• Medazepam


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Midazolam


• Morphine


• Morphine Sulfate Liposome


• Nalbuphine


• Nitrazepam


• Nordazepam


• Opium


• Oxazepam


• Oxycodone


• Oxymorphone


• Pentazocine


• Pentobarbital


• Phenobarbital


• Prazepam


• Propoxyphene


• Quazepam


• Remifentanil


• Secobarbital


• Sodium Oxybate


• Sufentanil


• Tapentadol


• Temazepam


• Thiopental


• Triazolam

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol


• Carbamazepine


• Doxepin


• Isoniazid


• Metoprolol


• Phenytoin


• Propranolol


• Warfarin


• Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cabbage

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of or


• Brain tumor, history of or


• Chronic obstructive pulmonary disease (COPD) or


• Cor pulmonale (serious heart condition) or


• Drug dependence, especially with narcotics, or history of or


• Gallbladder disease or gallstones or


• Head injuries, history of or


• Hypovolemia (low blood volume)—Use with caution. May increase risk for more serious side effects.

• Asthma, severe or


• Breathing problems, severe (e.g., hypoxia) or


• Paralytic ileus (intestine stops working and may be blocked) or


• Respiratory depression (very slow breathing) or


• Suicidal ideation (thoughts of hurting or killing oneself), history of—Should not be used in patients with these conditions.

• Hypotension (low blood pressure) or


• Pancreatitis (inflammation of the pancreas)—Use with caution. May make these conditions worse.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of propoxyphene and acetaminophen

This section provides information on the proper use of a number of products that contain propoxyphene and acetaminophen. It may not be specific to Propoxacet-N 100. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence). Liver damage can occur if large amounts of acetaminophen are taken for a long time.

This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For mild to moderate pain:
    
    • Adults—One or two tablets every 4 hours as needed. Your doctor may adjust your dose if needed. However, the dose is usually not more than 6 to 12 tablets per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw any unused medicine by mixing it with used coffee grounds or kitty litter and place it in a sealable bag, empty can, or container.

Precautions While Using Propoxacet-N 100

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Talk to your doctor first before you stop taking this medicine and changing to another pain medicine.

This medicine can cause changes in heart rhythms, such as conditions called PR, QRS, and QT prolongation. It may change the way your heart beats and cause fainting, dizziness, lightheadedness, or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Propoxacet-N 100 Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Abdominal or stomach pain


• chills


• clay-colored stools


• dark urine


• dizziness


• fever


• headache


• itching


• loss of appetite


• nausea


• rash


• unpleasant breath odor


• unusual tiredness or weakness


• vomiting of blood


• yellow eyes or skin

Incidence not known

• Bloating


• bloody or black, tarry stools


• bloody or cloudy urine


• change in consciousness


• chest pain or discomfort


• confusion


• cough


• decreased urine output


• difficult or troubled breathing


• dilated neck veins


• drowsiness


• extreme fatigue


• fainting


• fast, slow, pounding, or irregular heartbeat or pulse


• fever with or without chills


• general feeling of discomfort or illness


• hives


• hoarseness


• irregular, fast, slow, or shallow breathing


• itching


• joint pain, stiffness, or swelling


• light-colored stools


• loss of consciousness


• low blood pressure or pulse


• muscle aches and pains


• muscle tremors


• pain or discomfort in the arms, jaw, back, or neck


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pale or blue lips, fingernails, or skin


• rapid, deep breathing


• redness of the skin


• restlessness


• right upper stomach pain and fullness


• runny nose


• severe stomach pain


• shakiness and unsteady walk


• shivering


• shortness of breath


• sore throat


• stomach cramps


• sudden decrease in the amount of urine


• sweating


• swelling of the eyelids, face, fingers, lips, hands, lower legs, or feet


• thoughts of suicide


• tightness in the chest


• trouble sleeping


• troubled breathing or swallowing


• unconsciousness


• unsteadiness, trembling, or other problems with muscle control or coordination


• very slow breathing


• very slow heartbeat


• vomiting of blood or material that looks like coffee grounds


• weight gain


• wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Agitation


• bluish color of the fingernails, lips, skin, palms, or nail beds


• convulsion


• coughing that sometimes produces a pink frothy sputum


• decreased awareness or responsiveness


• depression


• difficult, fast, or noisy breathing, sometimes with wheezing


• dilated pupils


• hostility


• increased sweating


• irritability


• lethargy


• muscle tremors


• muscle twitching


• pale skin


• pounding or rapid pulse


• rapid weight gain


• rapid, deep breathing


• severe sleepiness


• sleepiness or unusual drowsiness


• slow to respond


• slurred speech


• weight loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Relaxed and calm feeling

Incidence not known

• Abnormal behavior


• blurred or loss of vision


• constipation


• diarrhea


• disturbed color perception


• double vision


• false or unusual sense of well-being


• halos around lights


• indigestion


• muscular pain, tenderness, wasting, or weakness


• night blindness


• nightmares or unusually vivid dreams


• overbright appearance of lights


• seeing, hearing, or feeling things that are not there


• swelling of the eye


• tunnel vision

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Propoxacet-N00 side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Propoxacet-N 100 resources

• Propoxacet-N 100 Side Effects (in more detail)
• Propoxacet-N 100 Use in Pregnancy & Breastfeeding
• Drug Images
• Propoxacet-N 100 Drug Interactions
• Propoxacet-N 100 Support Group
• 77 Reviews for Propoxacet-N00 - Add your own review/rating

Compare Propoxacet-N 100 with other medications

• Osteoarthritis
• Pain

Increlex 10mg / ml solution for injection

1. Name Of The Medicinal Product

Increlex 10mg/mL solution for injection.

2. Qualitative And Quantitative Composition

Each mL contains 10mg of mecasermin.

Each vial contains 40mg of mecasermin.

Mecasermin is a recombinant DNA-derived human insulin-like growth factor-1(IGF-1) produced in Escherichia coli.

Excipients:

One mL contains 9mg of benzyl alcohol.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection.

Aqueous, clear and colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

For the long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor-1 deficiency (Primary IGFD).

Severe Primary IGFD is defined by:

• height standard deviation score

• basal IGF-1 levels below the 2.5^th percentile for age and gender and

• GH sufficiency.

• Exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.

Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. It is recommended to confirm the diagnosis by conducting an IGF-1 generation test.

4.2 Posology And Method Of Administration

Treatment with Increlex should be directed by physicians who are experienced in the diagnosis and management of patients with growth disorders.

The dose should be individualised for each patient. The recommended starting dose of mecasermin is 0.04 mg/kg twice daily by subcutaneous injection. If no significant treatment-related adverse events occur for at least one week, the dose may be raised in increments of 0.04 mg/kg to the maximum dose of 0.12 mg/kg given twice daily. Doses greater than 0.12 mg/kg given twice daily have not been evaluated in children with severe Primary IGFD.

If the recommended dose is not tolerated by the subject, treatment with a lower dose can be considered. Treatment success should be evaluated based on height velocities. The lowest dose that was associated with substantial growth increases on an individual basis was 0.04 mg/kg BID.

Increlex should be administered shortly before or after a meal or snack. If hypoglycaemia occurs with recommended doses, despite adequate food intake, the dose should be reduced. If the patient is unable to eat, for any reason, Increlex should be withheld. The dose of mecasermin should never be increased to make up for one or more omitted doses.

Injection sites should be rotated to a different site with each injection.

Increlex should be administered using sterile disposable syringes and injection needles. The syringes should be of small enough volume that the prescribed dose can be withdrawn from the vial with reasonable accuracy.

Increlex is not recommended for use in children below age 2 due to a lack of data on safety and efficacy (see section 5.1).

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Intravenous administration.

Active or suspected neoplasia. Therapy should be discontinued if evidence of neoplasia develops.

Benzyl alcohol must not be given to premature babies or neonates.

4.4 Special Warnings And Precautions For Use

Thyroid and nutritional deficiencies should be corrected before initiating Increlex treatment.

Increlex is not a substitute for GH treatment.

Increlex should not be used for growth promotion in patients with closed epiphyses.

Increlex should be administered shortly before or after a meal or snack, because it may have insulin-like hypoglycaemic effects. Special attention should be paid to young children, children with a history of hypoglycaemia and children with inconsistent food intake. Patients should avoid engaging in any high-risk activities within 2-3 hours after dosing, particularly at the initiation of Increlex treatment, until a well tolerated dose of Increlex has been established. If a person with severe hypoglycemia is unconscious or otherwise unable to ingest food normally, an injection of glucagon may be required. Persons with a history of severe hypoglycemia should have glucagon available. At the time of initial prescription, physicians should educate parents on the signs, symptoms and treatment of hypoglycaemia, including injection of glucagon.

Doses of insulin and/or other hypoglycaemic agents may need to be reduced for diabetic subjects using Increlex.

Echocardiogram is recommended before initiation of Increlex treatment in all patients. Patients who terminate treatment should also have an echocardiogram. Patients with abnormal echocardiogram findings or cardiovascular symptoms should be followed regularly with echocardiogram procedures.

Lymphoid tissue (e.g., tonsillar) hypertrophy associated with complications, such as snoring, sleep apnoea, and chronic middle-ear effusions have been reported with the use of Increlex. Patients should have examinations periodically and at the occurrence of clinical symptoms to rule out such potential complications or to initiate appropriate treatment.

Intracranial hypertension (IH) with papilloedema, visual changes, headache, nausea and/or vomiting has been reported in patients treated with Increlex, as has been reported with therapeutic GH administration. IH-associated signs and symptoms resolved after interruption of dosing. Funduscopic examination is recommended at the initiation, periodically during the course of Increlex therapy and at the occurrence of clinical symptoms.

Slipped capital femoral epiphysis and progression of scoliosis can occur in patients who experience rapid growth. These conditions and other symptoms and signs known to be associated with GH treatment in general should be monitored during Increlex treatment. Any patient with the onset of a limp or complaint of hip or knee pain should be evaluated.

In post-marketing experience in patients treated with Increlex, cases of hypersensitivity, urticaria, pruritus and erythema have been reported. These have been observed both as local to the injection site and/or systemic. A small number of cases indicative of anaphylaxis requiring hospitalisation have been reported. Parents and patients should be informed that such reactions are possible and that if a systemic allergic reaction occurs, treatment should be interrupted and prompt medical attention should be sought.

Treatment should be reconsidered if after a year patients remain non-responsive.

Persons who have allergic reactions to injected IGF-1, who have unexpectedly high blood values of IGF-1 after injection, or who fail to show a growth response may be having an antibody response to injected IGF-1. In such instances, follow the instructions for antibody testing.

Increlex contains 9mg/mL benzyl alcohol as a preservative.

Benzyl alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interaction studies have been performed.

4.6 Pregnancy And Lactation

A negative pregnancy test and education about adequate contraception are recommended for all women of child bearing potential prior to treatment with Increlex.

There are no adequate data for the use of mecasermin in pregnant women.

Animal studies are insufficient with respect to pregnancy (see section 5.3). The potential risk for humans is unknown.

Increlex should not be used during pregnancy unless clearly necessary.

Breast-feeding while taking Increlex is not recommended.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed. However, hypoglycaemia may impair the ability to drive or use machines.

4.8 Undesirable Effects

An integrated safety database from clinical studies contains 76 subjects with severe Primary IGFD treated for a mean duration of 4.4 years and representing 321 subject-years.

Hypoglycaemia is the most frequently reported adverse drug reaction. The thirty-six subjects (47%) who had one or more episodes of hypoglycaemia included 4 subjects who had hypoglycaemic seizure on one or more occasion. Of the 36 subjects, 12 (33%) had a history of hypoglycaemia prior to beginning treatment. The frequency of hypoglycaemia was highest in the first month of treatment, and episodes were more frequent in younger children. Symptomatic hypoglycaemia was generally avoided when a meal or snack was consumed either shortly before or after the administration of Increlex.

Injection site hypertrophy occurred in 24 subjects (32%). This reaction was generally associated with lack of proper rotation of injections. When injections were properly dispersed, the condition resolved.

Tonsillar hypertrophy was noted in 12 (16%) subjects, particularly in the first 1 to 2 years of therapy with lesser tonsillar growth in subsequent years.

Snoring, generally beginning in the first year of treatment, was reported in 17 subjects (22%).

Hypoacusis was reported in 15 subjects (20%).

Intracranial hypertension occurred in three subjects (4%). In two subjects the events resolved without interruption of Increlex treatment. Increlex treatment was discontinued in the third subject and resumed later at a lower dose without recurrence. Fourteen subjects (18%) had headache considered related to study drug.

During clinical trials in other indications totalling approximately 300 patients, reports of local and/or systemic hypersensitivity were received for 8% of patients. All cases were mild or moderate in severity and none was serious.

As with all protein pharmaceuticals, some patients may develop antibodies to Increlex. Anti-IGF-1 antibodies were observed in 11 of 23 children with severe Primary IGFD tested during the first year of therapy. No attenuation of growth was observed as a consequence of the development of antibodies.

Table 1 contains very common (

Table 1: Adverse Drug Reactions in Clinical Trials

System Organ Class	Adverse Reaction
Very Common	Common
Investigations		Cardiac murmur, abnormal tympanometry, abnormal echocardiogram, increased alanine aminotransferase*, increased aspartate aminotransferase*, increased weight
Cardiac Disorders		Cardiomegaly, ventricular hypertrophy, atrial hypertrophy*, tachycardia, tachycardia paroxysmal*, mitral valve incompetence*, tricuspid valve incompetence*
Congenital, Familial and Genetic Disorders		Congenital jaw malformation, pigmented naevus*
Blood and Lymphatic System Disorders	Thymus hypertrophy	Lymphadenopathy*
Nervous System Disorders	Headache	Convulsions, febrile convulsion*, benign intracranial hypertension, loss of consciousness*, sleep apnoea syndrome, dizziness, tremor*, restless leg syndrome*
Eye Disorders		Papilloedema, reduced visual acuity*, myopia*
Ear and Labyrinth Disorders	Hypoacusis	Otorrhoea, ear disorder*, middle ear disorder*, tympanic membrane disorder*, ear pain, ear congestion*, fluid in middle ear
Respiratory, Thoracic and Mediastinal Disorders	Tonsillar hypertrophy, snoring	Adenoidal hypertrophy, nasal turbinate hypertrophy*, dyspnoea*, nasal mucosal disorder*, obstructive airway disorder*, abnormal respiration*, nasal congestion, mouth breathing
Gastrointestinal Disorders		Vomiting, retching*, abdominal pain*, upper abdominal pain*, abdominal distension*, dysphagia*
Renal and Urinary Disorders		Nephrolithiasis*, hydronephrosis*, renal colic*
Skin and Subcutaneous Tissue Disorders		Skin hypertrophy, acrochordons*, abnormal hair texture*
Musculoskeletal and Connective Tissue Disorders		Arthralgia, pain in extremity, myalgia, scoliosis*, spinal deformity*, soft tissue disorder*, muscle cramp*, flank pain*, musculoskeletal stiffness*
Metabolism and Nutrition Disorders	Hypoglycaemia	Hypoglycaemic seizure, hyperglycaemia, hyperlipidaemia*, obesity*
Infections and Infestations		Febrile infection*, upper respiratory tract infection*, otitis media, otitis media serous, chronic otitis media serous *, otitis externa*, pharyngitis*, tonsillitis, ear infection, oral candidiasis*
Surgical and Medical Procedures		Adenotonsillectomy*, adenoidectomy, ear tube insertion
General Disorders and Administration Site Conditions	Injection site hypertrophy	Mucosal membrane hyperplasia, hypertrophy, injection site pain, injection site bruising, injection site fibrosis*, injection site reaction*, injection site swelling*, injection site induration*, injection site pigmentation changes*, mucosal oedema*, asthenia*, lethargy*, chest discomfort*
Reproductive System and Breast Disorders		Gynaecomastia, ovarian cyst*
Psychiatric Disorders		Depression*, sleep terror, nervousness, abnormal behaviour*, disorientation*
* = occurred in only 1 subject (1%)

The following adverse reactions have been identified during post approval use of Increlex. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.

-Systemic hypersensitivity: anaphylaxis, generalised urticaria, angioedema, dyspnoea

The symptoms in the cases indicative of anaphylaxis included hives, angioedema and dyspnoea. Some patients required hospitalisation. Upon re-administration, symptoms did not re-occur in all patients.

-Local allergic reactions at the injection site: pruritis, urticaria.

4.9 Overdose

No case of overdose has been reported.

Acute overdose could lead to hypoglycaemia. Long-term overdose may result in signs and symptoms of acromegaly or gigantism.

Treatment of acute overdose of mecasermin should be directed at alleviating any hypoglycaemic effects. Oral glucose or food should be consumed. If the overdose results in loss of consciousness, intravenous glucose or parenteral glucagon may be required to reverse the hypoglycaemic effects.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Somatropin and agonists, ATC code: H01AC03

This medicinal product has been authorised under “Exceptional Circumstances”.

This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product.

The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary.

Mecasermin is a human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology. IGF-1 consists of 70 amino acids in a single chain with three intramolecular disulfide bridges and a molecular weight of 7649 daltons. The amino acid sequence of the product is identical to that of endogenous human IGF-1. The rhIGF-1 protein is synthesised in bacteria (E. coli) that have been modified by the addition of the gene for human IGF-1.

Insulin-like growth factor-1 (IGF-1) is the principal hormonal mediator of statural growth. Under normal circumstances, growth hormone (GH) binds to its receptor in the liver and other tissues, and stimulates the synthesis/secretion of IGF-1. In target tissues the Type 1 IGF-1 receptor, which is homologous to the insulin receptor, is activated by IGF-1, leading to intracellular signaling which stimulates multiple processes leading to statural growth. The metabolic actions of IGF-1 are in part directed at stimulating the uptake of glucose, fatty acids, and amino acids so that metabolism supports growing tissues.

The following actions have been demonstrated for endogenous human IGF-1:

Tissue Growth

• Skeletal growth is accomplished at the epiphyseal plates at the ends of a growing bone. Growth and metabolism of epiphyseal plate cells are directly stimulated by GH and IGF-1.

• Organ growth: treatment of IGF-1 deficient rats with rhIGF-1 results in whole body and organ growth.

• Cell growth: IGF-1 receptors are present on most types of cells and tissues. IGF-1 has mitogenic activity that leads to an increased number of cells in the body.

Carbohydrate Metabolism

IGF-1 suppresses hepatic glucose production, stimulates peripheral glucose utilization, and can reduce blood glucose and cause hypoglycaemia.

IGF-1 has inhibitory effects on insulin secretion.

Bone/Mineral Metabolism

Circulating IGF-1 plays an important role in the acquisition and maintenance of bone mass. IGF-1 increases bone density.

Clinical efficacy

Five clinical studies (4 open-label and 1 double-blind, placebo-controlled) were conducted with Increlex. Subcutaneous doses of mecasermin, generally ranging from 60 to 120 μg/kg given twice daily (BID), were administered to 76 paediatric subjects with severe Primary IGFD. Patients were enrolled in the studies on the basis of extreme short stature, slow growth rates, low IGF-1 serum concentrations, and normal GH secretion. Baseline characteristics for the patients evaluated in the primary and secondary efficacy analyses from the combined studies were (mean ± SD): chronological age (years): 6.8 ± 3.8; height (cm): 85.0 ± 15.3; height standard deviation score (SDS): -6.7 ± 1.8; height velocity (cm/yr): 2.8 ± 1.8; height velocity SDS: -3.3 ± 1.7; IGF-1 (ng/ml): 21.9 ± 24.8; IGF-1 SDS: -4.4 ± 2.0; and bone age (years): 3.9 ± 2.8. Sixty-two subjects had at least one year of treatment. Of these, 53 (85%) had Laron syndrome-like phenotype; 7 (11%) had GH gene deletion, and 1 (2%) had neutralizing antibodies to GH. Thirty-eight (61%) of the subjects were male; 49 (79%) were Caucasian. Fifty-six (90%) of the subjects were prepubertal at baseline.

Annual results for height velocity, height velocity SDS, and height SDS are shown in Table 2. Pre-treatment height velocity data were available for 59 subjects. The height velocities at a given year of treatment were compared by paired t-tests to the pre-treatment height velocities of the same subjects completing that treatment year.

Table 2: Annual Height Results by Number of Years Treated with Increlex

	Pre-Tx	Year 1	Year 2	Year 3	Year 4	Year 5	Year 6	Year 7	Year 8
Height Velocity (cm/yr)
N	59	59	54	48	39	21	20	16	14
Mean (SD)	2.8 (1.8)	8.0 (2.2)	5.8 (1.4)	5.5 (1.9)	4.7 (1.4)	4.7 (1.6)	4.8 (1.5)	4.6 (1.5)	4.5 (1.2)
Mean (SD) for change from pre-Tx		+5.2 (2.6)	+3.0 (2.3)	+2.6 (2.3)	+1.6 (2.1)	+1.5 (1.8)	+1.5 (1.7)	+1.0 (2.1)	+0.9 (2.4)
P-value for change from pre-Tx [1]		<0.0001	<0.0001	<0.0001	<0.0001	0.0015	0.0009	0.0897	0.2135
Height Velocity SDS
N	59	59	53	47	38	19	18	15	12
Mean (SD)	-3.3 (1.7)	1.9 (2.9)	-0.2 (1.6)	-0.3 (2.0)	-0.7 (1.9)	-0.6 (2.1)	-0.4 (1.4)	-0.4 (1.9)	-0.3 (1.8)
Mean (SD) for change from pre-Tx P-value for change from pre-Tx [1]		+5.1 (3.1) <0.0001	+3.2 (2.2) <0.0001	+3.1 (2.4) <0.0001	+2.5 (2.1) <0.0001	+2.5 (2.2) 0.0001	+2.7 (1.7) <0.0001	+2.5 (2.1) 0.0003	+2.8 (2.7) 0.0041
Height SDS
N	62	62	57	51	41	22	20	16	14
Mean (SD)	-6.7 (1.8)	-5.9 (1.7)	-5.6 (1.8)	-5.3 (1.8)	-5.3 (1.8)	-5.5 (1.8)	-5.4 (1.8)	-5.2 (2.0)	-5.2 (1.9)
Mean (SD) for change from pre-Tx P-value for change from pre-Tx [1]		+0.8 (0.5) <0.0001	+1.1 (0.8) <0.0001	+1.4 (1.0) <0.0001	+1.4 (1.1) <0.0001	+1.4 (1.3) <0.0001	+1.4 (1.2) <0.0001	+1.4 (1.1) 0.0001	+1.6 (1.1) <0.0001

Pre-Tx = Pre-treatment; SD = Standard Deviation; SDS = Standard Deviation Score

[1] P-values for comparison versus pre-Tx values were computed using paired t-tests.

Forty-seven subjects were included in an analysis of the effects of Increlex on bone age advancement. The mean ± SD change in chronological age was 5.1 ± 3.0 years and the mean ± SD change in bone age was 5.8 ± 2.9 years.

Efficacy is dose dependent. For subjects receiving doses between 100 and 120 μg/kg BID, the mean first year height velocity was approximately 8.7 cm/yr.

5.2 Pharmacokinetic Properties

GENERAL CHARACTERISTICS

Absorption

The absolute subcutaneous bioavailability of mecasermin in severe Primary IGFD subjects has not been determined. The bioavailability of mecasermin after subcutaneous administration in healthy subjects has been reported to be approximately 100%.

Distribution

In blood, IGF-1 is bound to six IGF binding proteins (IGFBPs), with ~80% bound as a complex with IGFBP-3 and an acid-labile subunit. IGFBP-3 is reduced in subjects with severe Primary IGFD, resulting in increased clearance of IGF-1 in these subjects relative to healthy subjects. The total IGF-1 volume of distribution (mean ± SD) after subcutaneous administration of Increlex in 12 subjects with severe Primary IGFD is estimated to be 0.257 (± 0.073) L/kg at a mecasermin dose of 0.045 mg/kg, and is estimated to increase as the dose of mecasermin increases. Limited information is available on the concentration of unbound IGF-1 after the administration of Increlex.

Metabolism

Both the liver and the kidney have been shown to metabolise IGF-1.

Excretion

The mean terminal t_1/2 of total IGF-1 after single subcutaneous administration of 0.12 mg/kg in three paediatric subjects with severe Primary IGFD is estimated to be 5.8 hours. Clearance of total IGF-1 is inversely proportional to serum IGFBP-3 levels and total IGF-1 systemic clearance (CL/F) is estimated to be 0.04 L/hr/kg at 3 mg/l IGFBP-3 in 12 subjects.

CHARACTERISTICS IN SPECIAL POPULATIONS

Geriatric

The pharmacokinetics of Increlex have not been studied in subjects greater than 65 years of age.

Children

The pharmacokinetics of Increlex have not been studied in subjects younger than 12 years of age.

Gender

In children over 12 years old with Primary IGFD and in healthy adults there were no apparent differences between males and females in the pharmacokinetics of Increlex.

Race

No information is available.

Renal insufficiency

No studies have been conducted in children with renal impairment.

Hepatic insufficiency

No studies have been conducted to determine the effect of hepatic impairment on the pharmacokinetics of mecasermin.

5.3 Preclinical Safety Data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity or genotoxicity.

Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:

Reproductive toxicity

In rats and rabbits reproductive toxicity was studied after intravenous but not after subcutaneous application (the normal clinical route). These studies did not indicate direct or indirect harmful effects with respect to fertility and pregnancy, but due to the different route of application the relevance of these findings is unclear. Placental transfer of mecasermin was not studied.

Carcinogenesis

Mecasermin was administered subcutaneously to Sprague Dawley rats at doses of 0, 0.25, 1, 4, and 10 mg/kg/day for up to 2 years. An increased incidence of adrenal medullary hyperplasia and pheochromocytoma was observed in male rats at doses of 1 mg/kg/day and above (

An increased incidence of keratoacanthoma in the skin was observed in male rats at doses of 4 and 10 mg/kg/day (

6. Pharmaceutical Particulars

6.1 List Of Excipients

Benzyl alcohol

Sodium chloride

Polysorbate 20

Glacial acetic acid

Sodium acetate

Water for injections

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

3 years

After opening:

Chemical and physical in-use stability has been demonstrated for 30 days at 2°C to 8°C.

From a microbiological point of view, once opened, the product may be stored for a maximum of 30 days at 2°C to 8°C. Other in-use storage times and conditions are the responsibility of the user.

6.4 Special Precautions For Storage

Store in a refrigerator (2°C - 8°C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

6.5 Nature And Contents Of Container

4mL of solution in a 5mL vial (type I glass) closed with a latex-free stopper (bromobutyl/isoprene polymer) and a seal (lacquered plastic).

Pack size of 1 vial.

6.6 Special Precautions For Disposal And Other Handling

Increlex is supplied as a sterile solution with preservative for multiple use.

The solution should be clear immediately after removal from the refrigerator. If the solution is cloudy, or contains particulate matter, it must not be injected.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Ipsen Pharma

65, quai Georges Gorse

92100 Boulogne-Billancourt

France

8. Marketing Authorisation Number(S)

EU/1/07/402/001

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 3^rd August 2007

10. Date Of Revision Of The Text

28^th July 2010

Pro-Banthine

propantheline bromide

Dosage Form: Tablets

Pro-Banthine Description

Pro-Banthine®(propantheline bromide) oral tablets contain 15 mg or 7.5 mg of the anticholinergic propantheline bromide, (2-hydroxyethyl) diisopropylmethylammonium bromide xanthene-9-carboxylate.

The structural formula of propantheline bromide is:

Propantheline bromide is very soluble in water, alcohol, and chloroform, but it is practically insoluble in ether and in benzene. Its molecular weight is 448.40.

Inactive Ingredients: include calcium carbonate, castor oil, corn starch, lactose anhydrous, light mineral oil, magnesium carbonate, magnesium stearate, saccharin sodium, sucrose, talc, titanium dioxide, and waxes. The 15-mg tablet also contains cosmetic ochre and cosmetic red as coloring agents.

Pro-Banthine - Clinical Pharmacology

Propantheline bromide inhibits gastrointestinal motility and diminishes gastric acid secretion. The drug also inhibits the action of acetylcholine at the post-ganglionic nerve endings of the parasympathetic nervous system.

Propantheline bromide is extensively metabolized in man primarily by hydrolysis to the inactive compounds xanthene-9-carboxylic acid and (2-hydroxyethyl) diisopropylmethylammonium bromide. After a single 30-mg oral dose given as two 15-mg tablets, the mean peak plasma concentration of propantheline was 21 ng/mL at 1 hour in 6 healthy subjects.

The plasma elimination half-life of propantheline is about 1.6 hours. Approximately 70% of the dose is excreted in the urine, mostly as metabolites. The urinary excretion of propantheline is about 3% after oral tablet administration.

Indications and Usage for Pro-Banthine

Pro-Banthine® (propantheline bromide) tablets are as effective as adjunctive therapy in the treatment of peptic ulcer.

Contraindications

Propantheline bromide is contraindicated in patients with:

1. Glaucoma, since mydriasis is to be avoided.


2. Obstructive disease of the gastrointestinal tract (pyloroduodenal stenosis, achalasia, paralytic ileus, etc.)


3. Obstructive uropathy (e.g., bladder-neck obstruction due to prostatic hypertrophy).


4. Intestinal atony of elderly or debilitated patients.


5. Severe ulcerative colitis or toxic megacolon complicating ulcerative colitis.


6. Unstable cardiovascular adjustment in acute hemorrhage.


7. Myasthenia gravis.

Warnings

In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of Pro-Banthine®.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with propantheline bromide would be inappropriate and possibly harmful.

With overdosage, a curare-like action may occur (i.e., neuromuscular blockage leading to muscular weakness and possible paralysis).

Propantheline bromide may cause increased heart rate and, therefore, should be used with caution in patients with heart disease.

Precautions

General

Propantheline bromide should be used with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, hypertension, or hiatal hernia associated with reflux esophagitis, since anticholinergics may aggravate this condition.

In patients with ulcerative colitis, large doses of propantheline bromide may suppress intestinal motility to the point of producing paralytic ileus and, for this reason, may precipitate or aggravate toxic megacolon, a serious complication of the disease.

Information for patients

Propantheline bromide may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work, while taking this drug product.

Drug Interactions

Anticholinergics may delay absorption of other medication given concomitantly.

Excessive cholinergic blockade may occur if propantheline bromide is given concomitantly with belladonna alkaloids, synthetic or semisynthetic anticholinergic agents, narcotic analgesics such as meperidine, Type 1 antiarrhythmic drugs (e.g. disopyramide, procainamide or quinidine), antihistamines, phenothiazines, tricyclic antidepressants, or other psychoactive drugs. Propantheline bromide may also potentiate the sedative effect of phenothiazines. Increased intraocular pressure may result from concurrent administration of anticholinergics and corticosteroids.

Concurrent use of propantheline bromide with slow-dissolving tablets of digoxin may cause increased serum digoxin levels. This interaction can be avoided by using only those digoxin tablets that rapidly dissolve by USP standards.

Carcinogenesis, mutagenesis, impairment of fertility

No long-term fertility, carcinogenicity, or mutagenicity studies have been done with propantheline bromide.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with propantheline bromide. It is also not known whether propantheline bromide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Propantheline bromide should be given to a pregnant woman only if clearly needed.

Nursing mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when propantheline bromide is administered to a nursing woman. Suppression of lactation may occur with anticholinergic drugs.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

Varying degrees of drying of salivary secretions may occur as well as decreased sweating. Ophthalmic side effects include blurred vision, mydriasis, cycloplegia and increased ocular tension. Other reported adverse reactions include urinary hesitancy and retention, tachycardia, palpitations, loss of the sense of taste, headache, nervousness, mental confusion, drowsiness, weakness, dizziness, insomnia, nausea, vomiting, constipation, bloated feeling, impotence, suppression of lactation, and allergic reactions or drug idiosyncrasies, including anaphylaxis, urticaria, and other dermal manifestations.

Overdosage

The symptoms of overdosage with propantheline bromide progress from an intensification of the usual side effects to CNS disturbances (from restlessness and excitement to psychotic behavior), circulatory changes (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis, and coma.

Measures to be taken are (1) immediate induction of emesis or lavage of the stomach, (2) injection of physostigmine 0.5 to 2 mg intravenously, repeated as necessary up to a total of 5 mg, and (3) monitoring of vital signs and managing as necessary.

Fever may be treated symptomatically (cooling blanket or alcohol sponging). Excitement of a degree which demands attention may be managed with thiopental sodium 2% solution given slowly intravenously, or diazepam, 5 to 10 mg intravenously or 10 mg intramuscularly. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, mechanical respiration should be instituted and maintained until effective respiratory action returns.

The oral LD50 of propantheline bromide is 780 mg/kg in the mouse and 370 mg/kg in the rat.

Pro-Banthine Dosage and Administration

The usual initial adult dosage of Pro-Banthine®tablets is 15 mg taken 30 minutes before each meal (3 times daily), and 30 mg at bedtime (a total of 75 mg daily). Subsequent dosage adjustment should be made according to the patient's individual response and tolerance. The administration of one 7.5-mg tablet 30 minutes before each meal (3 times daily) is convenient for patients with mild manifestations, for geriatric patients, and for those of small stature.

How is Pro-Banthine Supplied

Pro-Banthine®15-mg tablets are round, peach-colored, sugar-coated, with RPC imprinted on one side and 074 on the other side. Bottles of 100 (NDC 54092-074-01).

Pro-Banthine® 7.5-mg tablets are round, white, sugar-coated, with RPC imprinted on one side and 073 on the other side. Bottles of 100 (NDC 54092-073-01).

Store below 25°C (77°F).

Rev. 2/00 073 0117 004

PRO-BANTHINE  propantheline bromide  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54092-074 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength propantheline bromide (propantheline) Active 15 MILLIGRAM  In 1 TABLET calcium carbonate Inactive   castor oil Inactive   corn starch Inactive   lactose anhydrous Inactive   light mineral oil Inactive   magnesium carbonate Inactive   magnesium stearate Inactive   saccharin sodium Inactive   sucrose Inactive   talc Inactive   titanium dioxide Inactive   waxes Inactive   cosmetic ochre Inactive   cosmetic red Inactive

Product Characteristics Color PINK (PEACH) Score no score Shape ROUND Size 6mm Flavor Imprint Code RPC;074 Contains          Coating true Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 54092-074-01 100 TABLET In 1 BOTTLE None

PRO-BANTHINE  propantheline bromide  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54092-073 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength propantheline bromide (propantheline) Active 7.5 MILLIGRAM  In 1 TABLET calcium carbonate Inactive   castor oil Inactive   corn starch Inactive   lactose anhydrous Inactive   light mineral oil Inactive   magnesium carbonate Inactive   magnesium stearate Inactive   saccharin sodium Inactive   sucrose Inactive   talc Inactive   titanium dioxide Inactive   waxes Inactive

Product Characteristics Color WHITE Score no score Shape ROUND Size 6mm Flavor Imprint Code RPC;073 Contains          Coating true Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 54092-073-01 100 TABLET In 1 BOTTLE None

Revised: 03/2007Shire US Manufacturing Inc

More Pro-Banthine resources

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

• Pro-Banthine MedFacts Consumer Leaflet (Wolters Kluwer)


• Pro-Banthine Concise Consumer Information (Cerner Multum)


• Propantheline Bromide Monograph (AHFS DI)

Compare Pro-Banthine with other medications

• Peptic Ulcer

Cortaid Maximum Strength

Generic Name: hydrocortisone topical (hye droe KOR ti sone)

Brand Names: Ala-Cort, Ala-Scalp HP, Aquanil HC, Beta HC, Caldecort, Cortaid, Cortaid Intensive Therapy, Cortaid Maximum Strength, Cortaid with Aloe, Cortalo with Aloe, Corticaine, Cortizone for Kids, Cortizone-10, Cortizone-10 Intensive Healing Formula, Cortizone-10 Plus, Cortizone-5, Dermarest Dricort, Dermarest Eczema Medicated, Dermarest Plus Anti-Itch, Dermtex HC, Genasone/Aloe, Gly-Cort, Gynecort Maximum Strength, Hycort, Hydrocortisone 1% In Absorbase, Hydrocortisone with Aloe, Hydrocortisone-Aloe, Hytone, Instacort, Itch-X Lotion, Locoid, Locoid Lipocream, Locoid Lotion, Massengill Medicated Soft Cloth, MD Hydrocortisone, Neutrogena T-Scalp, NuCort with Aloe, NuZon, Pandel, Recort Plus, Rederm, Sarnol-HC, Scalacort, Texacort, U-Cort, Westcort

What is Cortaid Maximum Strength (hydrocortisone topical)?

Hydrocortisone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Hydrocortisone topical is used to treat inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, or psoriasis.

Hydrocortisone topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Cortaid Maximum Strength (hydrocortisone topical)?

There are many brands and forms of hydrocortisone topical available and not all brands are listed on this leaflet.

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

What should I discuss with my healthcare provider before using Cortaid Maximum Strength (hydrocortisone topical)?

Do not use this medication if you are allergic to hydrocortisone.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

FDA pregnancy category C. It is not known whether hydrocortisone topical is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hydrocortisone topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

How should I use Cortaid Maximum Strength (hydrocortisone topical)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger or smaller amounts, or use it for longer than recommended.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Wash your hands before and after each application, unless you are using hydrocortisone topical to treat a hand condition.

Apply a small amount to the affected area and rub it gently into the skin.

Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days. It is important to use hydrocortisone topical regularly to get the most benefit. Store hydrocortisone topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. An overdose of hydrocortisone topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using Cortaid Maximum Strength (hydrocortisone topical)?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use hydrocortisone topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Cortaid Maximum Strength (hydrocortisone topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using hydrocortisone topical and call your doctor at once if you have any of these serious side effects:

• 
  

  blurred vision, or seeing halos around lights;

  
  


• 
  

  uneven heartbeats;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  weight gain, puffiness in your face; or

  
  


• 
  

  feeling tired.

  
  

Less serious side effects may include:

• 
  

  skin redness, burning, itching, or peeling;

  
  


• 
  

  thinning of your skin;

  
  


• 
  

  blistering skin; or

  
  


• 
  

  stretch marks.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Cortaid Maximum Strength (hydrocortisone topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied hydrocortisone. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Cortaid Maximum Strength resources

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

• Ala-Cort Advanced Consumer (Micromedex) - Includes Dosage Information


• Anusol-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Carmol HC Prescribing Information (FDA)


• Carmol HC MedFacts Consumer Leaflet (Wolters Kluwer)


• Cortizone-10 Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Hydrocortisone Acetate Monograph (AHFS DI)


• Hydrocortisone with Aloe Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Hytone Prescribing Information (FDA)


• Instacort Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Lipocream Prescribing Information (FDA)


• Locoid Lotion Prescribing Information (FDA)


• Nutracort Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Pandel Prescribing Information (FDA)


• Pediaderm HC Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• ProctoCream-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Proctocort Prescribing Information (FDA)


• Texacort Prescribing Information (FDA)


• U-cort Prescribing Information (FDA)


• Westcort Prescribing Information (FDA)

Compare Cortaid Maximum Strength with other medications

• Anal Itching
• Aphthous Stomatitis, Recurrent
• Atopic Dermatitis
• Dermatitis
• Eczema
• Gingivitis
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Skin Rash

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone topical.

See also: Cortaid Maximum Strength side effects (in more detail)