Womens Laxative

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Womens Laxative Recall

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Side Effects & Adverse Reactions

Do not use

in children under 6 years of age
in persons who cannot swallow without chewing

Ask a doctor before use if you have

abdominal pain
nausea
vomiting
sudden change in bowel movements that persist over a period of 2 weeks

When using this product

do not use for a period longer than 1 week unless directed by a doctor
you may experience abdominal discomfort, faintness and cramps

Stop use and ask a doctor if

rectal bleeding occurs
you fail to have a bowel movement

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use

in children under 6 years of age
in persons who cannot swallow without chewing

Ask a doctor before use if you have

abdominal pain
nausea
vomiting
sudden change in bowel movements that persist over a period of 2 weeks

Stop use and ask a doctor if

rectal bleeding occurs
you fail to have a bowel movement

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

for gentle, overnight relief of occasional constipation (irregularity)
this product generally produces bowel movement in 6 to 12 hours

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History

There is currently no drug history available for this drug.

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Other Information

There are no additional details available for this product.

Sources

Womens Laxative Manufacturers

Rite Aid

Womens Laxative | Rite Aid

do not chew or crush tablets

do not take within 1 hour after taking an antacid or milk
adults and children over 12 years of age oral dosage is 1 to 3 tablets in a single or divided daily dose children 6 to under 12 years of age oral dosage is 1 tablet in a single daily dose children under 6 years of age ask a doctor

No Recall
Wal-mart Stores Inc

Womens Laxative | Dong Sung Pharm Co., Ltd.

Apply on wet hair, gently massage onto scalp, wait for 3 minutes and rinse thoroughly.

No Recall
Walgreen Co.

Womens Laxative | Walgreen Co.

do not chew or crush tablets do not take within 1 hour after taking an antacid or milk adults and children
over 12 years of age oral dosage is 1 to 3 tablets in
a single or divided daily dose children 6 to under
12 years of age oral dosage is 1 tablet in a
single dose children under
6 years of age ask a doctor

No Recall
Safeway

Womens Laxative | Upsher-smith Laboratories, Inc.

2.1 Initial Dosing
Morphine Sulfate Extended-release Capsules should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

Morphine Sulfate Extended-release 100 mg capsules are only for patients in whom tolerance to an opioid of comparable potency has been established. Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg of morphine daily, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid.

Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)]. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with Morphine Sulfate Extended-release Capsules [see Warnings and Precautions (5.2)].

Morphine Sulfate Extended-release Capsules must be taken whole. Crushing, chewing, or dissolving the pellets in Morphine Sulfate Extended-release Capsules will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.2)]. Patients who are unable to swallow Morphine Sulfate Extended-release Capsules should be instructed to sprinkle the capsule contents on applesauce and immediately swallow without chewing [see Administration of Morphine Sulfate Extended-release Capsules (2.4)].

Morphine Sulfate Extended-release Capsules are administered at a frequency of either once daily (every 24 hours) or twice daily (every 12 hours).

Use of Morphine Sulfate Extended-release Capsules as the First Opioid Analgesic

There has been no evaluation of Morphine Sulfate Extended-release Capsules as an initial opioid analgesic in the management of pain. Because it may be more difficult to titrate a patient to adequate analgesia using an extended-release morphine, begin treatment using an immediate-release morphine formulation and then convert patients to Morphine Sulfate Extended-release Capsules as described below.

Use of Morphine Sulfate Extended-release Capsules in Patients who are not Opioid Tolerant

The starting dose for patients who are not opioid tolerant is Morphine Sulfate Extended-release Capsules 30 mg orally every 24 hours. Patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, or an equianalgesic dose of another opioid.

Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.

Conversion from Other Opioids to Morphine Sulfate Extended-release Capsules

There are no established conversion ratios from other opioids to Morphine Sulfate Extended-release Capsules defined by clinical trials. Discontinue all other around-the-clock opioid drugs when Morphine Sulfate Extended-release Capsules therapy is initiated and initiate dosing using Morphine Sulfate Extended-release Capsules 30 mg orally every 24 hours.

While there are useful tables of opioid equivalents readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products. As such, it is safer to underestimate a patient's 24-hour oral morphine requirements and provide rescue medication (e.g. immediate-release morphine) than to overestimate the 24-hour oral morphine requirements which could result in an adverse reaction.

Conversion from Other Oral Morphine Formulations to Morphine Sulfate Extended-release Capsules

Patients receiving other oral morphine formulations may be converted to Morphine Sulfate Extended-release Capsules by administering one-half of the patient's total daily oral morphine dose as Morphine Sulfate Extended-release Capsules twice daily or by administering the total daily oral morphine dose as Morphine Sulfate Extended-release Capsules once daily. There are no data to support the efficacy or safety of prescribing Morphine Sulfate Extended-release Capsules more frequently than every 12 hours.

Morphine Sulfate Extended-release Capsules are not bioequivalent to other extended-release morphine preparations. Conversion from the same total daily dose of another extended-release morphine product to Morphine Sulfate Extended-release Capsules may lead to either excessive sedation at peak or inadequate analgesia at trough. Therefore, monitor patients closely when initiating Morphine Sulfate Extended-release Capsules therapy and adjust the dosage of Morphine Sulfate Extended-release Capsules as needed.

Conversion from Parenteral Morphine, or Other Opioids to Morphine Sulfate Extended-release Capsules

When converting from parenteral morphine or other non-morphine opioids (parenteral or oral) to Morphine Sulfate Extended-release Capsules, consider the following general points:
Parenteral to Oral Morphine Ratio: Between 2 mg and 6 mg of oral morphine may be required to provide analgesia equivalent to 1 mg of parenteral morphine. Typically, a dose of oral morphine that is three times the daily parenteral morphine requirement is sufficient.

Other Oral or Parenteral Opioids to Oral Morphine Sulfate: Specific recommendations are not available because of a lack of systematic evidence for these types of analgesic substitutions. Published relative potency data are available, but such ratios are approximations. In general, begin with half of the estimated daily morphine requirement as the initial dose, managing inadequate analgesia by supplementation with immediate-release morphine.
Conversion from Methadone to Morphine Sulfate Extended-release Capsules

Close monitoring is of particular importance when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.
2.2 Titration and Maintenance of Therapy
Individually titrate Morphine Sulfate Extended-release Capsules to a dose that provides adequate analgesia and minimizes adverse reactions at a frequency of either once or twice daily. Continually reevaluate patients receiving Morphine Sulfate Extended-release Capsules to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for the use of opioid analgesics.

If the level of pain increases, attempt to identify the source of increased pain, while adjusting the Morphine Sulfate Extended-release Capsules dose to decrease the level of pain. Because steady-state plasma concentrations are approximated within 24 to 36 hours, Morphine Sulfate Extended-release Capsules dosage adjustments may be done every 1 to 2 days.

Patients who experience breakthrough pain may require a dose increase of Morphine Sulfate Extended-release Capsules, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the Morphine Sulfate Extended-release Capsules dose. In patients experiencing inadequate analgesia with once daily dosing of Morphine Sulfate Extended-release Capsules, consider a twice daily regimen.

If unacceptable opioid-related adverse reactions are observed, the subsequent doses may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
2.3 Discontinuation of Morphine Sulfate Extended-release Capsules
When a patient no longer requires therapy with Morphine Sulfate Extended-release Capsules, use a gradual downward titration, of the dose every two to four days, to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue Morphine Sulfate Extended-release Capsules.
2.4 Administration of Morphine Sulfate Extended-release Capsules
Morphine Sulfate Extended-release Capsules must be taken whole. Crushing, chewing, or dissolving the pellets in Morphine Sulfate Extended-release Capsules will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.2)].

Alternatively, the contents of the Morphine Sulfate Extended-release Capsules (pellets) may be sprinkled over applesauce and then swallowed. This method is appropriate only for patients able to reliably swallow the applesauce without chewing. Other foods have not been tested and should not be substituted for applesauce. Instruct the patient to:
Sprinkle the pellets onto a small amount of applesauce and consume immediately without chewing. Rinse the mouth to ensure all pellets have been swallowed. Discard any unused portion of the Morphine Sulfate Extended-release Capsules after the contents have been sprinkled on applesauce.
The contents of the Morphine Sulfate Extended-release Capsules (pellets) may be administered through a 16 French gastrostomy tube.
Flush the gastrostomy tube with water to ensure that it is wet. Sprinkle the Morphine Sulfate Extended-release Pellets into 10 mL of water. Use a swirling motion to pour the pellets and water into the gastrostomy tube through a funnel. Rinse the beaker with a further 10 mL of water and pour this into the funnel. Repeat rinsing until no pellets remain in the beaker.
Do not administer Morphine Sulfate Extended-release pellets through a nasogastric tube.

No Recall
Western Family Foods, Inc.

Womens Laxative | Western Family Foods, Inc.

do not take more than 3 tablets daily adults and children 12 years of age and older take 1-3 tablets in a single dose once daily children 6 to under 12 years of age take 1 tablet daily children under 6 years of age consult a doctor

No Recall
Nash-finch Company

Womens Laxative | Hospira Worldwide, Inc.

NOTE: Aluminum reacts with carboplatin causing precipitate formation and loss of potency, therefore, needles or intravenous sets containing aluminum parts that may come in contact with the drug must not be used for the preparation or administration of Carboplatin Injection.

Single Agent Therapy: Carboplatin Injection, as a single agent, has been shown to be effective in patients with recurrent ovarian carcinoma at a dosage of 360 mg/m2 IV on day 1 every 4 weeks (alternatively see Formula Dosing). In general, however, single intermittent courses of Carboplatin Injection should not be repeated until the neutrophil count is at least 2000 and the platelet count is at least 100,000.

Combination Therapy with Cyclophosphamide: In the chemotherapy of advanced ovarian cancer, an effective combination for previously untreated patients consists of:

Carboplatin Injection - 300 mg/m2 IV on day 1 every four weeks for six cycles (alternatively see Formula Dosing).

Cyclophosphamide - 600 mg/m2 IV on day 1 every four weeks for six cycles. For directions regarding the use and administration of cyclophosphamide please refer to its package insert. (See CLINICAL STUDIES.)

Intermittent courses of Carboplatin Injection in combination with cyclophosphamide should not be repeated until the neutrophil count is at least 2000 and the platelet count is at least 100,000.

Dose Adjustment Recommendations: Pretreatment platelet count and performance status are important prognostic factors for severity of myelosuppression in previously treated patients.

The suggested dose adjustments for single agent or combination therapy shown in the table below are modified from controlled trials in previously treated and untreated patients with ovarian carcinoma. Blood counts were done weekly, and the recommendations are based on the lowest post-treatment platelet or neutrophil value.
Platelets Neutrophils Adjusted Dose* (From Prior Course) *Percentages apply to Carboplatin Injection as a single agent or to both Carboplatin Injection and cyclophosphamide in combination. In the controlled studies, dosages were also adjusted at a lower level (50% to 60%) for severe myelosuppression. Escalations above 125% were not recommended for these studies.
>100,000

>2000

125%

50-100,000

500-2000

No Adjustment

<50,000

<500

75%

Carboplatin Injection is usually administered by an infusion lasting 15 minutes or longer. No pre- or post-treatment hydration or forced diuresis is required.

Patients with Impaired Kidney Function: Patients with creatinine clearance values below 60 mL/min are at increased risk of severe bone marrow suppression. In renally-impaired patients who received single-agent Carboplatin Injection therapy, the incidence of severe leukopenia, neutropenia, or thrombocytopenia has been about 25% when the dosage modifications in the table below have been used.
Baseline Creatinine Clearance Recommended Dose on Day 1
41 - 59 mL/min

250 mg/m2

16 - 40 mL/min

200 mg/m2

The data available for patients with severely impaired kidney function (creatinine clearance below 15 mL/min) are too limited to permit a recommendation for treatment.

These dosing recommendations apply to the initial course of treatment. Subsequent dosages should be adjusted according to the patient’s tolerance based on the degree of bone marrow suppression.

Formula Dosing: Another approach for determining the initial dose of Carboplatin Injection is the use of mathematical formulae, which are based on a patient’s preexisting renal function or renal function and desired platelet nadir. Renal excretion is the major route of elimination for carboplatin. (See CLINICAL PHARMACOLOGY.) The use of dosing formulae, as compared to empirical dose calculation based on body surface area, allows compensation for patient variations in pretreatment renal function that might otherwise result in either underdosing (in patients with above average renal function) or overdosing (in patients with impaired renal function).

A simple formula for calculating dosage, based upon a patient’s glomerular filtration rate (GFR in mL/min) and Carboplatin Injection target area under the concentration versus time curve (AUC in mg/mL•min), has been proposed by Calvert. In these studies, GFR was measured by 51Cr-EDTA clearance.
CALVERT FORMULA FOR CARBOPLATIN DOSING
Total Dose (mg) = (target AUC) x (GFR + 25)

Note: With the Calvert formula, the total dose of Carboplatin Injection is calculated

in mg, not mg/m2.

The target AUC of 4-6 mg/mL•min using single agent Carboplatin Injection appears to provide the most appropriate dose range in previously treated patients. This study also showed a trend between the AUC of single agent Carboplatin Injection administered to previously treated patients and the likelihood of developing toxicity.

% Actual Toxicity in Previously Treated Patients

Gr 3 or Gr 4

Gr 3 or Gr 4

AUC (mg/mL•min)

Thrombocytopenia

Leukopenia

4 to 5

16%

13%

6 to 7

33

34%

Geriatric Dosing: Because renal function is often decreased in elderly patients, formula dosing of Carboplatin Injection based on estimates of GFR should be used in elderly patients to provide predictable plasma Carboplatin Injection AUCs and thereby minimize the risk of toxicity.

PREPARATION OF INTRAVENOUS SOLUTIONS

Carboplatin Injection 10 mg/mL is supplied as a Ready To Use (RTU) sterile solution in 5 mL, 15 mL, 45 mL or 60 mL vials. Total content of carboplatin per vial is described in following table:
Vial Strength Diluent Volume
50 mg

5 mL

150 mg

15 mL

450 mg

45 mL

600 mg

60 mL

Carboplatin Injection can be further diluted to concentrations as low as 0.5 mg/mL with 5% Dextrose in Water (D5W) or 0.9% Sodium Chloride Injection, USP.

When further diluted, Carboplatin Injection solutions are stable for 8 hours at room temperature (25°C). Since no antibacterial preservative is contained in the formulation, it is recommended that Carboplatin Injection solutions be discarded 8 hours after dilution.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

No Recall
H E B

Womens Laxative | H E B

do not chew or crush tablets

do not take within 1 hour after taking an antacid or milk
adults and children over 12 years of age oral dosage is 1 to 3 tablets in a single or divided daily dose children 6 to under 12 years of age oral dosage is 1 tablet in a single daily dose children under 6 years of age ask a doctor

No Recall
Great Lakes Wholesale, Marketing, & Sales, Inc.

Womens Laxative | Pd-rx Pharmaceuticals, Inc.

Dosage should be adjusted according to severity of pain and response of the patient.
The usual adult dosage is:

                                                     Single Doses                 Maximum
       Range         24-Hour Dose
Codeine Phosphate                     15mg to 60mg                 360 mg
Acetaminophen                        300 mg to 1000 mg            4000 mg

The usual dose of codeine phosphate in children is 0.5 mg/kg.

Doses may be repeated up to every 4 hours.

The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours, based upon the above dosage guidance. This information should be conveyed in the prescription.

It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.

No Recall
The Kroger Co.

Womens Laxative | The Kroger Co.

take with a glass of water adults and children 12 years of age and over take 1 to 3 tablets in a single daily dose children 6 to under 12 years of age take 1 tablet in a single daily dose children under 6 years of age ask a doctor

No Recall
Good Sense (Geiss, Destin & Dunn, Inc.)

Womens Laxative | Good Sense (geiss, Destin & Dunn, Inc.)

take with a glass of water adults and children 12 years of age and over take 1 to 3 tablets in a single daily dose children 6 to under 12 years of age take 1 tablet in a single daily dose children under 6 years of age ask a doctor

No Recall
Target Corporation

Womens Laxative | Target Corporation

take with a glass of water adults and children 12 years of age and over take 1 to 3 tablets in a single daily dose children 6 to under 12 years of age take 1 tablet in a single daily dose children under 6 years of age ask a doctor

No Recall
Top Care (Topco Associates Llc)

Womens Laxative | Top Care (topco Associates Llc)

take with a glass of water adults and children 12 years of age and over take 1 to 3 tablets in a single daily dose children 6 to under 12 years of age take 1 tablet in a single daily dose children under 6 years of age ask a doctor

No Recall
Amerisourcebergen Drug Corporation (Good Neighbor Pharmacy) 24385

Womens Laxative | Amerisourcebergen Drug Corporation (good Neighbor Pharmacy) 24385

take with a glass of water adults and children 12 years of age and over take 1 to 3 tablets in a single daily dose children 6 to under 12 years of age take 1 tablet in a single daily dose children under 6 years of age ask a doctor

No Recall
Quality Choice (Chain Drug Marketing Association)

Womens Laxative | Quality Choice (chain Drug Marketing Association)

take with a glass of water adults and children 12 years of age and over take 1 to 3 tablets in a single daily dose children 6 to under 12 years of age take 1 tablet in a single daily dose children under 6 years of age ask a doctor

No Recall